Do Medications Help Young ADHD Drivers Ignore Real World Distractions?

When a song on the radio or the cell phone on the car seat next to a young driver beckon, she may not resist the temptation to turn up the dial or take a call while maneuvering in traffic. Such distractions could lead to a car crash, especially for young drivers with Attention Deficit/Hyperactivity Disorder (ADHD).



As a group, young ADHD drivers are two to four times more likely to have a car accident than non-ADHD drivers. Daniel Cox, Ph.D., professor of psychiatry and neurosciences at the University of Virginia Health System, has conducted research aimed at improving those odds. His team's newest study will look at the effects of methylphenidate (MPH), a controlled-release stimulant, on young ADHD drivers facing real-life distractions.



"In controlled laboratory studies, there are no cell phones, no pressures to get home before curfew, no passengers encouraging the driver to 'get air,' no pets that slip from the driver's lap down to the pedals and no hamburger dripping with mustard in the driver's right hand," said Cox. "This, however, is real world driving. We want to investigate the benefits of medication in the context of such real world distractions and demands."



This research team's past studies have compared long- acting MPH to extended-release amphetamine salts and found that MPH is more effective in helping young ADHD drivers pay attention and have fewer driving mishaps while on the road. A second study Cox's team completed showed that ADHD young drivers fare better when driving cars with manual transmissions rather than automatic transmissions. In this latest study, funded by Shire Pharmaceuticals, Cox's team hopes to determine the benefits of MPH during routine, daily driving.



In the study, driver performance will be measured using a device called DriveCam. This video system will be mounted inside the vehicle and will measure and record all audio visual signals. When there is a marked change in driving force, DriveCam will store the 10 seconds before the change and the 20 seconds following the change. The study will last six months. For three months of the study, participants will receive MPH administered through a patch.



"We think that the drivers will perform better on the MPH patch than without the medication, even in light of real world situations," Cox said. "This information will help young ADHD drivers decide what approach may be best."

Do ADHD Drugs Cause Sudden Death?

This week, a study came out that scared us big-time ... it suggests that children and teens who take stimulants like Ritalin for ADHD have an increased risk for sudden cardiac death. Our pediatrician weighs in.


A new study in The American Journal of Psychiatry suggests that children and teens who take stimulants like Ritalin for ADHD have an increased risk for sudden cardiac death.


Researchers collected data on stimulant use among 564 children and teenagers who died unexpectedly of unknown causes and an equal number who died as passengers in auto accidents. Many of the unexplained deaths were later attributed to previously undiagnosed cardiac arrhythmias.



They concluded that the odds of using stimulant medication were six to seven times greater among the children who died suddenly of unexplained causes than among those who died in car crashes.


The FDA says, "Given the limitations of this study's methodology, the FDA is unable to conclude that these data affect the overall risk-and-benefit profile of stimulant medications used to treat ADHD in children."


Pediatrician Dr. Cara Natterson says: "Medications are not without risks. We say that to our patients repeatedly, but this most recent study reminds us of that fact very poignantly. There are many steps that doctors take when they prescribe stimulant medication in order to maximize safety: they make sure a patient really needs the medicine, they take histories and do physical exams, and they do baseline EKGs. What worries me is that many of these stimulant medications have developed a street following, with friends giving medicines to other friends or even selling them to peers. Adolescents and young adults often think these drugs are benign -- safe ways of increasing alertness and helping to pull an all-nighter. This study is a stark reminder that they are not."

Actavis Receives FDA Approval Of Atomoxetine HCl Capsules

Actavis has received approval from the U.S. Food & Drug Administration to market Atomoxetine HCl capsules for the treatment of attention deficit/hyperactivity disorder (ADHD).


Actavis intends to market Atomoxetine HCl in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths. No release date for Atomoxetine, Actavis' generic equivalent to Eli Lilly and Company's Strattera®, has been set. The U.S. Court of Appeals for the Federal Circuit is reviewing an Aug. 12 ruling that invalidated Lilly's patent, which is due to expire in 2017.


U.S. sales of Strattera® totaled $532 million for the 12-month period ended June 2010, according to IMS Health data.


Any statements contained in this press release that refer to Actavis' estimated or anticipated future results or future activities are forward-looking statements which reflect the Company's current analysis of existing trends, information and plans. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially depending on factors such as the availability of resources, the timing and effect of regulatory actions, the success of new products, the strength of competition, the success of research and development issues, unexpected contract breaches or terminations, exposure to product liability and other lawsuits, the effect of currency fluctuations and other factors.

Divorce Increases Risk Of Ritalin Use

Divorce puts children at higher risk of Ritalin use compared to kids whose parents stay together, says new research by a University of Alberta sociologist, who cautions that this doesn't necessarily mean that divorce is harmful to a child. The study appears in this week's issue of the Canadian Medical Association Journal.



Dr. Lisa Strohschein found that there is a "significantly higher" risk of Ritalin use - nearly twice as high - for children whose parents divorce compared to children whose parents remain together. It is the first study to follow children over time and evaluate whether experiencing parental divorce increases the risk for subsequent Ritalin use, a drug commonly prescribed for Attention Deficit Hyperactivity Disorder (ADHD). Previous studies have only compared the proportion of children taking Ritalin in two- biological parent homes versus single parent households. While such studies showed that living in a single parent household was a risk factor for Ritalin use, Strohschein suggests that a snapshot comparison across different family types provides an incomplete picture. There are a number of other ways--including being born to a never-married mother - that a child can come to live in a single-parent household.



"So the question was, 'is it possible that divorce acts a stressful life event that creates adjustment problems for children, which might increase acting out behaviour, leading to a prescription for Ritalin"'" said Strohschein.



She was drawn to look at Ritalin usage because prescriptions to children for Ritalin have skyrocketed over the past two decades, leading to concern over whether it is being appropriately prescribed.



Using data from the National Longitudinal Survey of Children and Youth (NLSCY) from 1994 to 2000, Strohschein restricted her sample to almost 5000 children who, at initial interview, lived in a two-biological parent household and were not Ritalin users. Between 1994 and 2000, 633 of these children (13.2 per cent) experienced the divorce of their parents. The percentage of children taking methylphenidate, or Ritalin, during that time was 3.3 per cent for children whose parents remained married and 6.1 per cent for children whose parents divorced during this time period. The findings complement previous research by showing that it is not just living in a single parent household, but parental divorce that is associated with greater risk.



One potential explanation for the higher use of Ritalin could be that divorce is stressful and some kids develop mental health problems and are then appropriately prescribed the drug, says Strohschein. "But a second possibility could be that ADHD has a genetic component so the association between parental divorce and Ritalin use in children exists because parents themselves have personality features that make it less likely their marriages will last," she said. "On the other hand there is also the very public perception that divorce is always bad for kids and so when children of divorce come to the attention of the health-care system - possibly because parents anticipate their child must be going through adjustment problems - doctors may be more likely to diagnose a problem and prescribe Ritalin.



"If this latter case is the real explanation, then there is the possibility that Ritalin is being prescribed inappropriately."



The message, says Strohschein, is to educate parents and doctors that not all kids develop mental health problems when their parents divorce. Instead, there is a need to look at the circumstances in the child's life before, during and after the divorce event to determine if the child is actually having problems coping. "In other words, it's too extreme to assume all children are adversely affected by divorce," she said. "We want to be very careful in ensuring that children who really need help receive treatment and avoid giving medication to kids who may not be well served by it."







This research was funded by the Social Sciences and Humanities Research Council of Canada.



For more information, please contact:



Dr. Lisa Strohschein, Faculty of Arts

University of Alberta



Phoebe Dey, Public Affairs

University of Alberta



Contact: Phoebe Dey


University of Alberta



View drug information on Ritalin LA.

Discovery By JHU Researcher That Brain Cells Have 'Memory'

As we look at the world around us, images flicker into our brains like so many disparate pixels on a computer screen that change every time our eyes move, which is several times a second. Yet we don't perceive the world as a constantly flashing computer display.



Why not?



Neuroscientists at The Johns Hopkins University think that part of the answer lies in a special region of the brain's visual cortex which is in charge of distinguishing between background and foreground images. Writing in a recent issue of the journal Neuron, the team demonstrates that nerve cells in this region (called V2) are able to "grab onto" figure-ground information from visual images for several seconds, even after the images themselves are removed from our sight.



"Recent studies have hotly debated whether the visual system uses a buffer to store image information and if so, the duration of that storage," said Rudiger von der Heydt, a professor in Johns Hopkins' Zanvyl Krieger Mind-Brain Institute, and co-author on the paper. "We found that the answer is 'yes,' the brain in fact stores the last image seen for up to two seconds."



The image that the brain grabs and holds onto momentarily is not detailed; it's more like a rough sketch of the layout of objects in the scene, von der Heydt explains. This may elucidate, at least in part, how the brain creates for us a stable visual world when the information coming in through our eyes changes at a rapid-fire pace: up to four times in a single second.



The study was based on recordings of activity in nerve cells in the V2 region of the brains of macaques, whose visual systems closely resemble that of humans. Located at the very back of the brain, V2 is roughly the size of a wristwatch strap.



The macaques were rewarded for watching a screen onto which various images were presented as the researchers recorded the animals' brain nerve cells' response. Previous experiments have shown that the nerve cells in V2 code for elementary features such as pieces of contour and patches of color. What is characteristic of V2, though, is that it codes these features with reference to objects. A vertical line, for instance, is coded either as the contour of an object on the left or as a contour of an object on the right. In this study, the researchers presented sequences of images consisting of a briefly-flashed square followed by a vertical line. They then compared the nerve cells' responses to the line when it was preceded by a square on the left and when it was preceded by a square on the right. The recordings revealed that the V2 cells remember the side on which the square had been presented, meaning that the flashing square set up a representation in the brain that persisted even after the image of the square was extinguished.



Von der Heydt said that discovering memory in this region was quite a surprise because the usual understanding is that neurons in the visual cortex simply respond to visual stimulation, but do not have a memory of their own.



Though this research is only a small piece of the "how people see and process images" puzzle, it's important, according to von der Heydt.



"We are trying to understand how the brain represents the changing visual scene and knows what is where at any given moment," von der Heydt said. "How does it delineate the contours of objects and how does it remember which contours belong to each object in a stream of multiple images? These are important and interesting questions whose answer may someday have very practical implications. For instance, how we function under conditions that strain our ability to process all relevant information - whether it be driving in city traffic, surveying a large crowd to find someone, or something else, may depend in large part on what kind of short-term memory our visual system has."



Understanding how this brain function works is more than just interesting. Because this study shows how the strength and duration of the memory trace can be directly measured, it may eventually be possible to understand its mechanism and to identify factors that can enhance or reduce this important function. This could assist researchers in unraveling the causes of - and perhaps even identifying treatment for - disorders such as attention deficit disorder and dyslexia.


Notes:


Philip O'Herron of the Johns Hopkins School of Medicine is a co-author on this study, which was supported by grants from the National Institutes of Health.



Source:
Lisa De Nike


Johns Hopkins University

Disconnect Between Brain Regions In ADHD

Two brain areas fail to connect when children with attention deficit hyperactivity disorder attempt a task that measures attention, according to researchers at the UC Davis Center for Mind and Brain and M.I.N.D. Institute.



"This is the first time that we have direct evidence that this connectivity is missing in ADHD," said Ali Mazaheri, postdoctoral researcher at the Center for Mind and Brain. Mazaheri and his colleagues made the discovery by analyzing the brain activity in children with ADHD. The paper appears in the current online issue of the journal Biological Psychiatry.



The researchers measured electrical rhythms from the brains of volunteers, especially the alpha rhythm. When part of the brain is emitting alpha rhythms, it shows that it is disengaged from the rest of the brain and not receiving or processing information optimally, Mazaheri said.



In the experiments, children with diagnosed ADHD and normal children were given a simple attention test while their brain waves were measured. The test consisted of being shown a red or blue image, or hearing a high or low sound, and having to react by pressing a button. Immediately before the test, the children were shown either a letter "V" to alert them that the test would involve a picture (visual), or an inverted "V" representing the letter "A" to alert them that they would hear a sound (auditory).



The experiments were conducted by researchers in the laboratories of Ron Mangun, professor of psychology and neurology, and Blythe Corbett, associate clinical professor of psychiatry and behavioral sciences and a researcher at the M.I.N.D. Institute.



According to current models of how the brain allocates attention, signals from the frontal cortex -- such as the "V" and "A" cues -- should alert other parts of the brain, such as the visual processing area at the back of the head, to prepare to pay attention to something. That should be reflected in a drop in alpha wave activity in the visual area, Mazaheri said.



And that is what the researchers found in the brain waves of children without ADHD. But children with the disorder showed no such drop in activity, indicating a disconnection between the center of the brain that allocates attention and the visual processing regions, Mazaheri said.



"The brains of the children with ADHD apparently prepare to attend to upcoming stimuli differently than do typically developing children," he said.



Children with ADHD did improve their reaction times when properly cued, but they don't seem to allocate resources as efficiently, Mazaheri said.



This is the first evidence from brain electrical patterns for a functional disconnection in cortical attention systems in ADHD, he said. Current definitions of ADHD are based only on behavior.



The research was originally inspired by a desire to combine laboratory and clinical research to go beyond existing measures of ADHD and get a better understanding of the condition, Corbett said.



"Clearly the crosstalk from bedside to bench has been fruitful," she said.



Other co-authors on the paper are staff research associate Sharon Corina, postdoctoral fellow Evelijn Bekker and research assistant Anne Berry.



The study was funded by the grants from the National Institutes of Health, the Netherlands Organization for Scientific Research, the Perry Family Foundation, the Debber Family Foundation and the Aristos Academy.



Source:
Andy Fell


University of California - Davis

Disappointment At No Action On Food Additives To Protect Children, UK

Several nutrition and medical groups in the UK have expressed their disappointment and outrage at the Food Standard's Agency's (FSA's) refusal to act on food additives. A recent report has shown that several additives have a significant impact on ADHD in children - in fact, Professor Jim Stevenson, who carried out the research, stated that additives pose a threat to children's psychological health. The FSA Board Meeting decided to pass the buck on to the European Food Safety Authority.


According to the FSA, the evidence so far is not compelling enough to justify a ban. However, FSA chairman Dame Deirdre Hutton, said "I think there is a general astonishment that industry has not responded more quickly to consumer demand in terms of taking colors out of their food."


The FSA also decided to slightly widen the range of its advice to parents of children with ADHD (Attention Deficit Hyperactivity Disorder), but not for parents of all children. The recent study showed that food additives have an impact in attention and hyperactivity in most children, not just susceptible ones.


Some action is being taken by several retailers, who are taking additives out of their own-label products. However, nothing has been done so far regarding school meals, takeaways (takeouts), restaurants and medications for children.


Richard Watts, coordinator of Sustain's Children's Food Campaign said: "Professor Stevenson, who undertook the study on additives, told the FSA that there was the evidence necessary to ban these additives because they do pose a threat to health. Parents will be furious that the FSA has chickened out of taking this vital step to protect their children. It is simply not good enough to give consumers a bit more help to avoid these unnecessary additives. Consumers are clear they don't want to have to spend ages scanning labels to see if a product will threaten the health of their child. And people do not see the label on around half the food and drink they consume. A ban on these additives is the only appropriate step."


-- Childhood Hyperactive Behaviors Exacerbated By Food Additives And Artificial Color


-- Click here to view the study on food additives and their effects of children


Written by: Christian Nordqvist

Diminished Proactive Attention Exoerienced By Action Video Game Players

Video game players are often accused of passively reacting to tasks that are spoon fed to them through graphics and stimuli on the screen. A group of researchers from Iowa State University shows that playing lots of video games has different effects on two types of cognitive activity, proactive and reactive attention.



Proactive attention can be thought of as a sort of "gearing up" mechanism. For instance, when players that are familiar with a particular game anticipate an action they need to take, such as getting a key or a pot of gold, in order to get to the next level. Reactive control is described as happening "just in time", for example, when a monster suddenly appears that is about to thwart the player's advantage or ability to get to the next level.



The study was published in the latest issue of Psychophysiology and used a simple visual task to test the two types of attention by measuring brain waves and behavioral responses. This task measured how proactive and reactive attention differed in frequent video game players vs. occasional players. In the task, individuals identified the color of a word when the color and word matched, such as "RED" presented in red, or did not match, such as "RED" presented in blue or green. It takes longer to indicate the color when the word does not match.



The researchers found that the just-in-time form of control was similar in the two groups of gamers. In contrast, brain wave and behavioral measures of proactive attention (the "gearing up" mechanism") were significantly diminished in the frequent video game players. These data reveal a reduction in brain activity and disruption of behavior associated with sustained attention ability related to video game experience, which converges with other recent findings indicating that there is a relation between frequent video game playing and ADD. This negative relationship between action games and proactive attention can be contrasted with the beneficial effects of these games on other aspects of visual processing. The research team is also exploring whether non-gamers who play action games produce the same results as those found in frequent players.



To view the abstract for this article, please click here.



Source:
Bethany Carland-Adams


Wiley-Blackwell

Determining Prevalence Of ADHD Adverse Medication Events, AACAP And APA Pledge To Work With FDA

The American Academy of Child and Adolescent Psychiatry (AACAP) and the American Psychiatric Association (APA) pledged to work with the Food and Drug Administration (FDA) Drug Safety and Risk Management Advisory Committee on determining the prevalence of rare, unexpected, and serious adverse events that occasionally occur in clinical trials for medications used in the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD).


Child and adolescent psychiatrist Laurence Greenhill, M.D. testified today on behalf of the AACAP and APA and said, "Stimulant medications offer many benefits to a wide range of children, and have proven to be safe over a half-century of use." The AACAP and the APA are committed to working with the FDA to strengthen safeguards for the treatment of children and adolescents with ADHD. To access Dr. Greenhill's full testimony, please visit the AACAP's website at http:// aacap.


ADHD is one of the most common psychiatric disorders in children and adolescents. The Centers for Disease Control and Prevention estimates that approximately 3,500,000 youth in the United States are taking stimulants as part of their treatment plan. Although medication is not the only treatment option, it can be an important part of a treatment plan for a child with ADHD. Large-scale, long-term, randomized clinical trials show the efficacy of long-term medication treatment and the important role of psychosocial interventions. Research demonstrates that medication can be extremely effective and even lifesaving for many children and adolescents with ADHD, and is most beneficial when used as a component of a comprehensive treatment plan. Medication allows many children with ADHD to sit and concentrate in class and lessens the likelihood of rejection by peers.


ADHD medications constitute the largest group of medications approved for use by the FDA for the treatment of children with behavioral problems. Stimulant medications are some of the most extensively studied medications used for the treatment of behavior disorders in children and adolescents. There have been over 200 controlled studies over the past 50 years. These drugs produce robust responses in over two thirds of affected youth by lowering the intensity of their ADHD symptoms.


The AACAP and APA realize the importance of identifying rare, unexpected adverse events and determining their prevalence. Only then can the partnership of parent and practitioner make an informed decision regarding the benefit-risk ratio involved in starting medication treatment. Besides the physiological risks of taking medications, alternatively, not treating ADHD can lead to possible school failure, substance abuse and increased probability of entrance into the juvenile justice system, if not treated appropriately.


The AACAP and APA are committed to working with the FDA to determine the prevalence of rare, unexpected, and serious adverse events to better estimate risk for taking these medications. The Child and Adolescent Psychiatry Trial Network (CAPTN), sponsored by NIMH and AACAP, is a large simple trials network and is one avenue to study these issues. This practice network will provide protocol-driven, postmarking surveillance for youth treated with ADHD medications to track such low frequency adverse events prospectively.


The AACAP and the APA have recommended to Congress and the FDA the formation of a pediatric and adolescent Central Nervous System Advisory Committee comprised of experts including child and adolescent psychiatrists and pediatric neurologists which would provide the agency expertise on pediatric psychopharmacology. The AACAP has been a long-standing advocate on behalf of a publicly accessible national registry of clinical trials. Physicians and parents need access to all clinical trial data to make fully informed decisions about their treatment options for all mental illnesses. Finally, the shortage of pediatric mental health clinicians and researchers are needed to appropriately diagnose and treat children and adolescents with mental illnesses and we urge support for legislation to address this shortage.


To view the Food and Drug Administration's Drug Safety and Risk Management Advisory Committee Feb. 9-10, 2006 briefing information, click here.


http:// aacap

Delayed-Release Stimulant Used To Treat Attention-Deficit Hyperactivity Disorder (ADHD) May Be Less Likely To Be Abused Than Other Stimulant Drugs

A team led by Massachusetts General Hospital (MGH) researchers has found that a delayed-release stimulant used to treat attention-deficit hyperactivity disorder (ADHD) may be less likely to be abused than other stimulant drugs. Study participants taking therapeutic oral doses of Concerta, a once-daily form of the drug methylphenidate, did not report perceiving and enjoying the drug's subjective effects, features that are associated with a medication's potential for abuse. The report appears in the March 2006 issue of The American Journal of Psychiatry.



"We know that drugs that cause euphoria are potentially abusable, and euphoria requires rapid delivery to the brain. Using sophisticated PET scan imaging, we were able to examine the rate of delivery of both rapid- and delayed-release formulations of methylphenidate and correlate those results with how the drugs felt to study volunteers," says Thomas Spencer, MD, of the MGH Pediatric Psychopharmacology Unit, the paper's lead author. "The ability to show that rate of brain delivery may determine abuse potential is important to our understanding of the safety of different formulations."



Methylphenidate and other stimulant drugs used to treat ADHD act by blocking the dopamine transporter, a molecule on brain cells that takes up the neurotransmitter dopamine, raising its level in the brain. Studies have shown that the brains of ADHD patients have abnormal regulation of dopamine, which plays a key role in the control of movement, behavior and attention. While stimulants are effective for controlling ADHD symptoms, the drugs are also subject to abuse, so the current study was designed to compare the abuse potential of two formulations of methylphenidate.



The researchers compared a traditional, quick-release form of the drug with Concerta, a formulation that is released over 12 hours to produce a gradual increase in blood levels. With Concerta, the drug passes slowly through a hole in capsules that do not dissolve, reducing the possibility that the gradual-release feature might be bypassed. Study participants received the two medications at dosages designed to produce comparable peak levels in the blood and brain.



Twelve adult volunteers, none diagnosed with ADHD or any neurological or psychiatric disorder, were randomly assigned to receive either the immediate-release or delayed-release form of methylphenidate on two separate days. PET scans - which showed whether or not the dopamine transporter molecule was occupied by the medication - were taken the day before drug administration as a baseline, one and three hours after the first drug administration and five and seven hours after a second drug administration on a different day. During the 10 hours after each drug administration, hourly blood samples were taken from the volunteers, who also completed hourly questionnaires regarding whether they were aware of the drug's effects and whether they enjoyed or disliked those effects.
















As expected, the delayed-release formulation took longer to produce maximum blood levels and blockade of the dopamine transporter than did the immediate-release drug. While most of those receiving immediate-release methylphenidate reported detecting and enjoying the drug's activity, few of those receiving the delayed-release form were aware of or enjoyed the drug's effects.



"The differing reports on feeling and liking the drug effects occurred despite using larger doses of the delayed-release formulation and the equivalent peak blood and brain levels," says Spencer. "Previous studies have showed that both versions are effective for treating ADHD. Whether delayed- or sustained-release formulations of other potentially abusable ADHD drugs share the same safety characteristics needs be studied, since different forms vary in the levels and timing of drug delivery." Spencer is an associate professor of Psychiatry at Harvard Medical School.







The study was supported by grants from the National Institute of Mental Health and McNeil Consumer & Specialty Pharmaceuticals, which manufactures Concerta. The study's co-authors are Joseph Biederman, MD, Bertha Madras, PhD, and Darin Dougherty, MD, of MGH Psychiatry; Ali Bonab, PhD, Elijahu Livni, PhD, and Alan Fischman, MD, PhD, of MGH Radiology; and Patrick Ciccone, MD, and Dolly Parasrampuria, PhD, of McNeil.



Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of nearly $500 million and major research centers in AIDS, cardiovascular research, cancer, cutaneous biology, medical imaging, neurodegenerative disorders, transplantation biology and photomedicine. In 1994, MGH and Brigham and Women's Hospital joined to form Partners HealthCare System, an integrated health care delivery system comprising the two academic medical centers, specialty and community hospitals, a network of physician groups, and nonacute and home health services.



Contact: Sue McGreevey



Massachusetts General Hospital



View drug information on Concerta.

Daytrana Provides Significant Effectiveness In Both Boys And Girls With ADHD

Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) has announced that DAYTRANA™ (methylphenidate transdermal system), its Attention Deficit Hyperactivity Disorder (ADHD) patch, had significant efficacy in reducing the symptoms of ADHD in both male and female children aged 6 to 12 years, according to clinical trial results reported at the American Psychiatric Association (APA) annual meeting in San Diego.



"Few clinical studies have examined gender differences in the response to ADHD treatments. Our study documented that DAYTRANA offered a favorable safety profile and was an effective ADHD treatment in both boys and girls," said Robert Findling, M.D., lead investigator and Professor of Psychiatry at Case Western Reserve University and Director of the Division of Adolescent and Child Psychiatry at University Hospitals Case Medical Center. "The study provides a platform to open a dialogue about gender and ADHD."



Approximately 4.4 million U.S. children aged 4 to 17 years -- about 7.8 percent of all school-age children -- have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). Studies estimated that 11.0 percent of boys have been diagnosed with ADHD in contrast to only 4.4 percent of girls. Experts believe that girls with ADHD are underdiagnosed and, therefore, undertreated.



Shire's DAYTRANA is the first and only patch medication approved by the U.S. Food and Drug Administration (FDA) to treat the symptoms of ADHD in children aged 6 to 12 years. DAYTRANA is available in four dosage strengths - 10 mg, 15 mg, 20 mg and 30 mg - all designed for once-daily use. When worn for the recommended nine hours, efficacy has been demonstrated from the first time point measured (two hours) through the 12-hour time point. Because Daytrana is a patch, physicians may recommend that patients shorten the wear time if shorter duration of effect is desired or to help manage the potential for late-day side effects.



Significant Symptom Control for Boys and Girls In this double-blind, 7-week, parallel-group study, investigators randomized 270 children to receive DAYTRANA, OROS methylphenidate or placebo. The 96 children (ITT population) in the DAYTRANA group reported a significant mean reduction of 56.5 percent in their ADHD Rating Scale-IV (ADHD-RS-IV) total scores (-24.24-14.55 points, P

DAYTRANA (methylphenidate Transdermal System) Significant Reduces ADHD Symptoms

Philadelphia, US - Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced that its methylphenidate transdermal system (MTS), DAYTRANA TM demonstrated statistically significant reductions in the symptoms of Attention Deficit Hyperactivity Disorder (ADHD) and was generally well tolerated in patients aged 6 to 12 years in four analyses of two clinical trials reported at a major medical meeting in Toronto.


"Children with ADHD and their caregivers must manage symptom control throughout the day in a variety of settings, such as the classroom, after-school activities, or home," explained clinical trials principal investigator Sharon Wigal, Ph.D., associate clinical professor of pediatrics at the University of California Irvine Child Development Center. "These studies document that a methylphenidate transdermal 'skin' patch formulation is an effective, once-daily ADHD treatment that can result in the improvement of multiple measures of behavior and classroom performance."


DAYTRANA was approved by the U.S. Food and Drug Administration (FDA) for once-daily use to treat Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years on April 6, 2006. DAYTRANA is the first and only non-oral medication for ADHD. Shire expects DAYTRANA to be available in pharmacies in mid 2006.


Data from phase II and phase III clinical trials presented Wednesday in Toronto demonstrated that DAYTRANA is a generally well-tolerated and effective treatment for ADHD in children as shown through improvements in the primary and secondary endpoints analyzed for children treated with DAYTRANA compared to children treated with placebo.


DAYTRANA was developed by Noven Pharmaceuticals, Inc., and combines the active ingredient, methylphenidate, with Noven's patented DOT Matrix? transdermal technology. This transdermal delivery system was designed to provide continuous medication release throughout the day. The patch is designed to stay on during the normal daily activities of a child such as swimming, exercising or bathing.


Because DAYTRANA is a patch, physicians can manage the duration of its effect and potential side effects by having the patient wear the patch for a shorter time period than the recommended nine hours on a given day. The patch is available in four dosage strengths - 10 mg, 15 mg, 20 mg and 30 mg - all designed for nine-hour wear times with 12-hour efficacy.


Phase II Analog Classroom Study


The phase II analog classroom study included 79 children with ADHD. DAYTRANA was assessed during a nine-hour wear time. The participants treated with DAYTRANA demonstrated statistically significant improvement based on the primary study measure, the standard Swanson, Kotkin, Agler, M-Flynn, and Pelham-Deportment (SKAMP-D) scale, in which higher ratings reflect greater impairment. Overall, participants using DAYTRANA significantly reduced their SKAMP-D scores to an average of 3.2 points compared to an average score of 8.0 points for those on placebo (P < .0001) from baseline.















Similarly, the DAYTRANA group significantly reduced their average total scores on two secondary measures from baseline, the SKAMP-attention subscale and SKAMP total subscale, to 6.2 and 9.4, respectively, compared to those on placebo, which had scores of 9.9 and 17.9 (P

DAYTRANA (methylphenidate Transdermal System) Provides Individualized ADHD Symptom Management

Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced that its Attention Deficit Hyperactivity Disorder (ADHD) patch, DAYTRANA tm (methylphenidate transdermal system), has significant efficacy in reducing the symptoms of ADHD in children aged 6 to 12 years, even when the ADHD patch is taken off earlier than the recommended nine hours. The ability to remove the patch earlier than the recommended nine-hour wear time allows physicians the opportunity to manage the potential for late-day side effects, such as lack of appetite or difficulty sleeping. These phase IIIb clinical trial results were reported 27-Oct-2006 at a major scientific and educational meeting of child and adolescent psychiatrists in San Diego, Calif.



"The patch's delivery system offers physicians individualized control of their patients' ADHD symptoms, adding an important dimension to the treatment of ADHD, since a child's schedule often varies between school day and weekend," explained Timothy E. Wilens, M.D., Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical School. "Because it is a patch, if a child sleeps late on the weekend and the patch is applied later than on a school day, it can still be removed at the usual time. That way, the child receives the benefit of their long-acting ADHD medication for a shorter duration of effect, as well as managing the potential for late-day side effects. The physician, in consultation with the parent, can determine the appropriate patch wear time, up to the recommended nine hours."



Shire's DAYTRANA is the first and only patch medication approved by the U.S. Food and Drug Administration (FDA) to treat the symptoms of pediatric ADHD. DAYTRANA is available in four dosage strengths - 10 mg, 15 mg, 20 mg and 30 mg - all designed for once-daily use. When worn for the recommended nine hours, efficacy has been demonstrated from the first time point measured (two hours) through the 12-hour time point.



Noven Pharmaceuticals, Inc. developed DAYTRANA, which combines the active ingredient, methylphenidate, with Noven's patented DOT Matrix? transdermal technology. This transdermal delivery system was designed to provide continuous medication release throughout the day. The patch is designed to stay on during the normal daily activities of a child such as swimming, exercising or bathing.



Significant Symptom Control With DAYTRANA When Worn for Four or Six Hours In this study, investigators researched the duration of symptom control of DAYTRANA when the patch was worn for four and six hours compared to a placebo patch. Study results were based on the children's scores on the primary study measure, the standard Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale deportment (SKAMP-D), a standardized, validated classroom assessment tool used for evaluating the behavioral symptoms of ADHD. Higher SKAMP-D ratings reflect greater impairment.
















Improvement in the SKAMP-D scores for both the four- and six-hour wear time groups was seen at the first time point measured (2 hours), compared to placebo. When DAYTRANA was removed after four and six hours of wear time, mean SKAMP-D scores began to return toward baseline within two hours of patch removal. A similar effect was observed by the Permanent Product Measure of Performance (PERMP) test of the number of math problems attempted and completed correctly.



Study Design


In the three-way cross-over study, 117 children aged 6 to 12 years diagnosed with ADHD were started on the 10-mg patch, and the dosage was increased during a five-week period until the optimal DAYTRANA dose was reached. The laboratory classroom study period covered three weeks including one classroom laboratory day per week, with the patients wearing the patch for nine hours for days in between the classroom laboratory days. Then, on the three laboratory classroom days only, the researchers randomized the children to treatment with a placebo patch or a DAYTRANA patch and either four- or six-hour wear times, but neither the investigators nor the children knew which treatment was received until study end. The results reported in this poster were based on analyses of the intent-to-treat population.



Study Safety Information


DAYTRANA was generally well-tolerated during this study. Adverse events typically were mild to moderate and were consistent with known effects of methylphenidate. The most common adverse events seen in the trial included: decreased appetite, headache, insomnia and upper abdominal pain.



Important Safety Information



Tell your doctor about any heart conditions, including structural abnormalities, your child or a family member may have. Inform your doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting.



Daytrana should not be used if the child has: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients of Daytrana; glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette's syndrome.



Tell your doctor before using Daytrana if the child: is being treated for or has symptoms of depression (e.g. sadness, worthlessness, or hopelessness) or bipolar disorder; has family history of tics; has abnormal thoughts or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell your doctor immediately if the child develops any of these conditions/symptoms while using Daytrana.



Daytrana was generally well tolerated in clinical studies. The most common side effects reported with Daytrana were decreased appetite, sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics, and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. Tell your doctor if the child has blurred vision while using Daytrana.



Abuse of Daytrana can lead to dependence.



Patients converting from another formulation of methylphenidate should start on the 10-mg DAYTRANA patch. Daytrana should be applied daily to clean, dry skin, which is free of any cuts or irritation. Skin irritation or allergic skin rash may occur.






The study was supported by funding from Shire.



SHIRE

725 Chesterbrook Blvd

Wayne, PA 19087

shire/



For Full Prescribing Information on Daytrana, please visit daytrana/ or call Shire Medical Affairs.



About ADHD

Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). ADHD is one of the most common psychiatric disorders in children and adolescents. ADHD is a neurobiological psychiatric disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; at least six of nine symptoms of hyperactivity/impulsivity; the onset of such symptoms before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning.



Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.



SHIRE PLC



Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.



Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.



For further information on Shire, please visit the Company's website: shire/.


"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995



Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (guanfacine extended release) (ADHD), SPD465 (extended release of mixed amphetamine salts) (ADHD), MESAVANCE (mesalamine) with MMX technology (SPD 476) (ulcerative colitis), ELAPRASE (idursulfase) (Hunter Syndrome) and NRP104 (lisdexamfetamine dimesylate) (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2005.



Daytrana™ is a trademark of Shire Pharmaceuticals Ireland Limited.



Contact: Matthew Cabrey

Porter Novelli



View drug information on Elaprase.

Abnormal brain anatomy in children with ADHD

Children with attention deficit hyperactivity disorder (ADHD) display anatomical brain abnormalities beyond chemical
imbalance, according to research presented at the annual meeting of the Radiological Society of North America (RSNA).
Stimulant medications prescribed to balance brain chemistry appear to normalize some of these brain irregularities, a second
study reported.


"We found abnormality of the fiber pathways in the frontal cortex, basal ganglia, brain stem and cerebellum," said lead
author of both studies, Manzar Ashtari, PhD., associate professor of radiology and psychiatry at North Shore-Long Island
Jewish Health System in New Hyde Park, N.Y.



"These areas are involved in the processes that regulate attention, impulsive behavior, motor activity, and inhibition--the
key symptoms in ADHD children," Dr. Ashtari said. "They are also known to be part of a bigger circuit in the brain that
establishes communication between the frontal lobe and cerebellum."


According to the National Institute of Mental Health (NIMH), ADHD affects 3 to 5 percent of children in the United States.
Children with ADHD have difficulty controlling their behavior or focusing their attention.


Using diffusion tensor imaging (DTI) to compare 18 children with diagnosed ADHD with 15 control children to evaluate the
brain's white-matter fiber development, Dr. Ashtari's team found differences in the brain fiber pathways that transmit and
receive information among brain areas.


"Typically ADHD is described as a chemical imbalance, but our research has shown that there may also be subtle anatomical
differences in areas of the brain that are important in this disorder," said co-principal investigator Sanjiv Kumra, M.D., a
psychiatrist at the Zucker Hillside Hospital in Glen Oaks, N.Y.


In the second study, the researchers found that children who had received stimulant treatment for ADHD had fewer white matter
abnormalities than children who did not receive medication.


Patients consisted of two groups, each comprised of 10 children with ADHD. The first group had not taken medication or had
been minimally exposed to medications. The second group was exposed to stimulants for an average of 2.5 years. Each of these
groups was compared with 10 age- and gender-matched controls. The medicated ADHD children exhibited a normalization effect in
fiber pathways of several brain areas.


"The findings from this small, cross-sectional study indicate that the therapeutic effect of stimulants may involve a brain
normalization process," Dr. Kumra said.


Most people diagnosed with ADHD in childhood continue to have problems in adolescence and adulthood. "Despite progress in the
assessment, diagnosis and treatment of ADHD, this disorder and its treatment have remained controversial," said co-author of
the stimulant study, Andrew Adesman, M.D. "This study is yet further proof that children with ADHD differ at a
neurobiological level as compared to children without the disorder." Dr. Adesman is chief of developmental and behavioral
pediatrics at Schneider Children's Hospital in New Hyde Park, N.Y.


Dr. Ashtari said further studies with larger patient groups must be conducted before offering parents advice for diagnosis or
treatment.


Co-authors are Babak Ardekani, Ph.D., Shree Bhaskar, M.D., Tana Clarke, B.S., and Joseph Rhinewine, M.A. (DTI study only).
The research was sponsored by an NIMH grant.


Note: Copies of RSNA 2004 news releases and electronic images will be available online at http://rsna/press04 beginning Monday, Nov. 29.


RSNA is an association of more than 37,000 radiologists, radiation oncologists and related scientists committed to promoting
excellence in radiology through education and by fostering research, with the ultimate goal of improving patient care. The
Society is based in Oak Brook, Ill.


Editor's note: The data in these releases may differ from those in the printed abstract and those actually presented at the
meeting, as researchers continue to update their data right up until the meeting. To ensure you are using the most up-to-date
information, please call the RSNA newsroom at (312) 949-3233 between Nov. 27 and Dec. 3.


Contact: Maureen Morley



630-590-7762

Radiological Society of North America

Dacogen(TM) Approved For Patients With All FAB Classifications Of MDS

MGI PHARMA, INC.(Nasdaq: MOGN) and SuperGen, Inc. (Nasdaq: SUPG) today
announced that the U.S. Food and Drug Administration (FDA) has approved
Dacogen(TM) (decitabine) for Injection. Dacogen is indicated for treatment
of patients with myelodysplastic syndromes (MDS) including previously
treated and untreated, de novo, and secondary MDS of all
French-American-British (FAB) subtypes (refractory anemia, refractory
anemia with ringed sideroblasts, refractory anemia with excess blasts,
refractory anemia with excess blasts in transformation, and chronic
myelomonocytic leukemia), and Intermediate-1, Intermediate-2, and High-Risk
International Prognostic Scoring System (IPSS) groups. MGI PHARMA plans to
make Dacogen commercially available during the second quarter of 2006.


"The FDA approval of Dacogen marks an important advancement for
patients who suffer from MDS," said John M. Bennett, M.D., Chair of The
Myelodysplastic Syndromes Foundation. "Patients with this serious condition
are often anemic, experience fatigue and weakness and, in certain cases
with an increase in leukemic blast cells, MDS can result in bone marrow
failure."


Results from a phase 3 clinical trial demonstrated an overall response
rate of 21% in Dacogen-treated patients considered evaluable for response,
defined as those patients with pathologically confirmed MDS at baseline who
received at least 2 cycles of treatment, compared to 0% in the supportive
care arm. All patients who responded to Dacogen treatment became or
remained transfusion independent during the time of the response. The most
commonly occurring adverse reactions with Dacogen include neutropenia,
thrombocytopenia, anemia, pyrexia, fatigue, nausea, cough, petechiae,
constipation, and diarrhea. It is recommended that patients be treated with
Dacogen for a minimum of four cycles, and treatment may continue as long as
the patient continues to benefit.


"The approval of Dacogen demonstrates MGI PHARMA's ability to identify,
acquire, develop, and register promising products," said Lonnie Moulder,
president and chief executive officer of MGI PHARMA. "We look forward to
providing clinicians with an effective therapy to offer their MDS patients.
MGI PHARMA is committed to continuing the development of Dacogen for
patients with acute myeloid leukemia, chronic myelogenous leukemia, and
solid tumors, in addition to developing alternative dosing regimens for
patients with MDS."















"This approval is a significant milestone for SuperGen. Over the course
of more than seven years, SuperGen developed Dacogen by working with
scientists, clinicians, patient advocacy groups, and regulatory agencies to
get this product approved for patients with MDS," said James S. Manuso,
Ph.D., President and CEO of SuperGen. "The approval of Dacogen is a
significant benefit for patients because of the drug's ability to address
the underlying disease and, potentially, to improve patient outcomes."


Summary of Clinical Results


SuperGen conducted a randomized open-label, multicenter, controlled
trial that evaluated 170 adult patients with myelodysplastic syndromes
meeting FAB classification criteria and IPSS High-Risk, Intermediate-2 and
Intermediate-1 prognostic scores. Eighty-nine patients were randomized to
Dacogen therapy plus supportive care, 83 of whom received Dacogen, and 81
were randomized to supportive care alone. Dacogen was intravenously infused
at a dose of 15 mg/m2 over a 3-hour period, every eight hours, for three
consecutive days. Dacogen therapy was repeated every 6 weeks, depending on
the patient's clinical response and toxicity. Supportive care consisted of
blood and blood product transfusions, prophylactic antibiotics, and
hematopoietic growth factors. Co-primary endpoints of the study were
overall response rate (complete responses plus partial responses) and time
to acute myeloid leukemia (AML) or death. Secondary endpoints included
hematologic improvement, duration of response, cytogenetic response rate,
transfusion requirements, quality of life, survival, and safety.


The overall response rate in the Dacogen study arm was 17% with a
median response duration of 288 days, compared to 0% in the supportive care
arm (p

Curemark To Present At BioPharm America&trade; 2010

Curemark, LLC, a drug research and development company focused on the treatment of neurological diseases, will present at BioPharm America™ 2010, to be held September 15-17 in Boston at the Marriott Boston Copley Place, the company announced.


Dr. Joan Fallon, Curemark's founder and CEO, will provide an overview of the company's enzyme replacement therapy targeted to autism. Curemark is now in Phase III clinical trials for CM-AT, its autism treatment. She will also discuss the Investigational New Drug (IND) authorization Curemark recently received from the U.S. Food and Drug Administration (FDA) for the use of the company's compound CM-4612 to treat attention deficit hyperactivity disorder (ADHD). The FDA has given clearance to Curemark's Investigational New Drug (IND) application for a Phase III clinical trial to study the use of CM-4612 in the treatment of ADHD.


"We are very pleased to be able to give a presentation at this year's BioPharm America," Fallon said. "We welcome the opportunity to discuss our momentum with therapies that address neurological conditions for which there are currently no viable, physiologically-based treatments."


CM-AT, Curemark's autism treatment, targets enzyme deficiencies in autistic children that affect the availability of amino acids, the building blocks of chemicals essential for brain function. The company is currently conducting Phase III CM-AT trials at 13 sites nationwide with a planned total of 170 children. If approved, CM-AT, which has been granted Fast Track status from the FDA, will be one of the first therapies to address the underlying physiology of autism.


Organized by EBD Group, a leading partnering firm for the global life sciences industry, BioPharm America is intended as a forum where biotech and pharma executives from around the world can meet, and identify and enter strategic relationships. BioPharm America 2010 is the third annual international partnering conference.


Safe Harbor Statement


This news release contains forward-looking statements that involve risks and uncertainties that could cause our actual results and experiences to differ materially from anticipated results and expectations expressed in such forward-looking statement. These forward-looking statements include, without limitation, statements regarding the mechanism of action of CM-AT, its potential advantages, its potential for use in treating autism, as well as the timing, progress and anticipated results of the clinical development and regulatory processes concerning CM-AT. These statements are based on our current beliefs and expectations as to such future outcomes, and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a material difference include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of CM-AT, our ability to finance our development of CM-AT, regulatory risks, and our reliance on third party researchers and other collaborators. We assume no obligation to update these statements, except as required by law.


Source: Curemark, LLC

Critical Early Step Of Memory Formation Discovered By Johns Hopkins Neuroscientists

Researchers at the Johns Hopkins University School of Medicine report in Neuron how nerve cells in the brain ensure that Arc, a protein critical for memory formation, is made instantly after nerve stimulation. Paradoxically, its manufacture involves two other proteins - including one linked to mental retardation - that typically prevent proteins from being made.



Previous research already established that long-term memory formation depends on Arc protein, but scientists did not know the mechanism that turned on this process.



To find it, they surveyed proteins in mouse brains that change or are activated after a nerve is stimulated and identified eEF2K (short for eukaryotic elongation factor 2 kinase) as a player. When turned on, eEF2K inhibits an important step of protein translation.



"This seemed strange, because it suggested that nerve cells might make Arc protein by using pathways typically thought to turn off protein manufacture," says Paul Worley, M.D., a professor of neuroscience in the Johns Hopkins University School of Medicine.



Further examination of mouse brain slices lacking eEF2K in their nerve cells showed that when stimulated, such cells fail to make the usual pools of Arc protein, demonstrating that eEF2K is required for making Arc.



What it didn't tell them was whether eEF2K specifically was responsible, or whether some other pathway is also involved, so researchers next treated the brain slices from normal mice with a chemical that inhibits protein manufacture by the same mechanism as eEF2K. At the same time that general protein synthesis was turned down, Arc translation actually increased, making it clear eEF2K, through its ability to turn down protein manufacture, somehow enabled a nerve cell to make Arc in response to nerve stimulation.



Meanwhile, Worley's team proceeded to build on research showing that a protein linked to a form of mental retardation passed on by an abnormal "fragile X" chromosome also represses the manufacture of some proteins. The researchers looked at Arc protein levels in nerve cells lacking the fragile X mental retardation protein and found stable levels of Arc protein all the time, before, during, after and even without stimulation of the nerve cells. They concluded that without fragile X protein, the presumed "brakes" on the system, the manufacture of Arc goes unregulated.



"It's sort of a seesaw relationship," Worley says. When nerve cells are stimulated, eEF2K is activated to suppress protein manufacture generally, thereby allowing for the rapid manufacture of Arc, and, at the same time, fragile X mental retardation protein is stimulated to let Arc protein get made.



"By defining a mechanism that is associated with fragile X syndrome - the most common inherited cause of mental retardation and autism - it may help others to identify potential therapeutic targets to help with the disease," Worley says.







The research was funded by the National Institute of Mental Health, the National Institute on Drug Abuse, and the National Institute on Aging.



Authors on the paper are Sunjin Park, Joo Min Park, Sangmok Kim, Jin-Ah Kim, Jason D. Shepherd, Constance L. Smith-Hicks, Shoaib Chowdhury, Walter Kaufmann, Dietmar Kuhl, Alexey G. Ryazanov, Richard L. Huganir, David J. Linden, and Worley, all of Hopkins.



On the Web:



http://neuroscience.jhu/


http://neuroscience.jhu/PaulWorley.php


neuron/



Source: Maryalice Yakutchik


Johns Hopkins Medical Institutions

Creativity Is An Upside To ADHD

Parents who believe that attention deficit hyperactivity disorder makes their kids more creative got a little more scientific support recently.


A new study in the Journal of Personality and Individual Differences found adults with ADHD enjoyed more creative achievement than those who didn't have the disorder.


"For the same reason that ADHD might create problems, like distraction, it can also allow an openness to new ideas," says Holly White, assistant professor of cognitive psychology at Eckerd College in St. Petersburg, Florida and co-author of the paper. "Not being completely focused on a task lets the mind make associations that might not have happened otherwise."


White and Priti Shah at the University of Michigan gave 60 college students half of them with ADHD a series of tests measuring creativity across 10 domains. The ADHD group scored higher across the board. The ADHD group showed more of a preference for brainstorming and generating ideas than the non-ADHD group, which preferred refining and clarifying ideas.


The study is a follow-up to one done in 2006, which focused on laboratory measures of creativity and found that ADHD individuals show better performance on tests of creative divergent thinking. "We didn't know if that would translate into real-life achievement," says Shah. "The current study suggests that it does."


Please let me know if there's anything further that I can provide, or if I can e-mail you a pdf of the study, "Creative style and achievement in adults with attention-deficit/hyperactivity disorder." We help Eckerd College with some of its public affairs work.


Source: Dick Jones Communications

Coverage For Children's Mental Illness Reduces Out-of-Pocket Spending, USA

State regulations requiring equal insurance coverage for mental illness does not increase usage and reduces out-of-pocket expenditures for families who have children with mental illness, a Yale School of Medicine study reports in the journal Health Services Research.


"Prior research has left policymakers with the impression that state parity laws will neither break the bank nor confer much benefit," said Colleen Barry, assistant professor in the Department of Epidemiology & Public Health and lead author of the study. "But our study indicates that these laws are providing important economic benefits to families of mentally ill children. This information may be important to policymakers considering enacting parity or expanding existing laws."


Barry and Susan Busch, associate professor in the Department of Epidemiology & Public Health, said health plans typically provide less insurance coverage for mental health compared with other medical care. Many states have passed mental health parity laws in an effort to improve equity in private insurance and reduce financial risk for those with mental illness.


At the federal level, Congress is currently considering two competing versions of comprehensive parity legislation. Prior research has demonstrated that mental health benefits can be offered on par with other medical services without significantly increasing total health insurance costs. Studies also indicate that state parity laws have had little effect on the use of mental health services. But prior to the release of this study, Barry and Busch said little has been known about how state policies affect the financial burden of seeking mental health treatment.


Using data from The Centers for Disease Control and Prevention 2000 National Survey of Children with Special Health Care Needs, the researchers examined how state parity laws affect out-of-pocket health care spending and other measures of the financial burden of treatment costs on families. Results indicate that living in a parity state significantly reduced the financial burden on families of children with mental health care needs. Specifically, the authors detect significantly lower out-of-pocket health care spending among families with children needing mental health care living in parity states compared with those in states without parity laws. Forty percent fewer families in parity states report their child's health care has caused financial problems.


The project was supported by a grant from the Robert Wood Johnson Foundation through its Changes in Health Care Financing and Organization initiative, which supports research, demonstration, and evaluation projects examining major changes in health care financing.


yale

Couples With Children With ADHD At Risk Of Higher Divorce Rates, Shorter Marriages

Parents of a child with attention deficit hyperactivity disorder (ADHD) are nearly twice as likely to divorce by the time the child is 8 years old than parents of children without ADHD, the first study to look at this issue in depth has shown.



Moreover, among couples in the study who were divorced, marriages involving children with ADHD ended sooner than marriages with no ADHD-diagnosed children.



William E. Pelham, Jr., Ph.D., professor of psychology and pediatrics at the University at Buffalo and director of UB's Center for Children and Families, is senior author on the study. Pelham is known internationally for his ADHD treatment and research, and each year conducts UB's Summer Treatment Program, a highly successful behavior-modification program that has helped hundreds of children with ADHD and has been replicated nationwide.



Brian T. Wymbs, who received his doctorate in clinical psychology at UB and is completing a postdoctoral fellowship at Western Psychiatric Institute and Clinic in Pittsburgh, Pa., is first author.



Results of the study appear in the October issue of the Journal of Consulting and Clinical Psychology.



Additional findings from a subset of divorced couples with children with ADHD showed that several characteristics within the family contribute individually to the risk of divorce: age of the child when diagnosed; race and ethnicity of the parents; severity of coexisting disorders in children with ADHD, such as oppositional-defiant disorder (ODD) and conduct disorder (CD); education levels of the parents; and a father's antisocial behavior (trouble with the law.)



"We believe this is the first study to find that both parent and child factors individually predict the rate and time of divorce," said Pelham. "Moreover, this is the only study to demonstrate that the severity of the child's disruptive behavior, specifically those with ODD or CD, increases the risk of divorce.



"Certainly we are not suggesting that having a child with ADHD is the only reason these marriages end in divorce," noted Pelham. "Disruptive child behavior likely interacts over time with other existing stress in the family to spark conflict in a marriage and, ultimately, divorce." Wymbs' research documents that when parents interact with an ADHD child, they are more distressed, argue with one another more and view one another as less supportive, compared to when they interact with a child without ADHD.



Data for the study was gathered from a subset of participants in a larger investigation called the Pittsburgh ADHD Longitudinal Study (PALS), which is funded by grants from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA) to Pelham and Brooke Molina, Ph.D., from the University of Pittsburgh.
















Some 282 adolescents and young adults who had been diagnosed with the disorder in childhood and their parents completed a series of questionnaires and diagnostic instruments, along with individual interviews. The child's birth date was used as the starting point of the time to divorce.



These results were compared with those from 206 demographically similar PALS participants without ADHD and their parents.



Results showed that 22.7 percent of parents of children with ADHD had divorced by the time the child was 8 years old, compared to 12.6 percent of parents in the control group. Divorce rates of parents with and without children with ADHD were not significantly different after children passed the 8-year mark.



"Families that 'survive' through that age, perhaps because they are low on all of the risk factors, apparently will make it through the rest of the child's childhood," Pelham said.



Of the characteristics that may contribute to risk of divorce, a father's antisocial behavior proved to be the largest factor. The rate of divorce also increased when mothers had substantially less education than fathers; children were diagnosed with ADHD at a younger age; families had racial or ethnic minority children and children had serious ODD or CD behavior problems. "With these findings in mind," Wymbs and Pelham said, "those who treat children with ADHD and disruptive behavior problems should take note if parents are having marriage problems and try to intervene to prevent the children from going through the trauma of divorce."



However, they also pointed out that for some couples who may have serious and frequent marital conflict and are raising difficult-to-manage children, divorce may be the best option for the children.


Notes:



Additional researchers on the study were Elizabeth M. Gnagy from UB, Brooke Molina and Tracey Wilson from the University of Pittsburgh, and Joel Greenhouse from Carnegie Mellon University.



The University at Buffalo is a premier research-intensive public university, a flagship institution in the State University of New York system that is its largest and most comprehensive campus. UB's more than 28,000 students pursue their academic interests through more than 300 undergraduate, graduate and professional degree programs. Founded in 1846, the University at Buffalo is a member of the Association of American Universities.



Source:

John DellaContrada

University at Buffalo

Cost Control Measures Limit Patient And Physician Choice In Psychotropic Medications

A new Brandeis University study published online in Clinical Therapeutics suggests that private health plans increasingly rely on escalating copayments to manage drug costs, as opposed to administrative controls. This makes treatment more expensive in many cases for patients, and may affect adherence to treatment, said lead author Dominic Hodgkin, associate professor at the Schneider Institute for Behavioral Health, Heller School for Social Policy and Management at Brandeis University.



In the past decade, health insurers have increasingly turned to cost controls to manage prescription drug use, but little is known about how such policies affect the use of psychotropic drugs, said Hodgkin. Between 1996 and 2001, psychotropic drug use to treat psychiatric disorders climbed from 5.9 percent to 8.1 percent of the U.S. population. Newer, better tolerated drugs account for some of the growth; however, because they are often more expensive than more established treatments, psychotropic drug spending has skyrocketed, from an estimated $3.7 billion in 1991 to $18 billion in 2001.



"This growth has raised concern among public and private health care payers, who have responded with cost-containment policies that affect the choices of patients and physicians," explained Hodgkin. The study evaluated brand antidepressants, antipsychotics and drugs used to treat attention-deficit hyperactivity disorder (ADHD).



Medicaid programs, by contrast, rely on administrative controls to manage psychotropic drug costs. These controls include prior authorization by a physician before a patient can switch to a non-preferred drug at the same copayment level. Further complicating the picture, patient non-compliance rates are high for psychotropic drugs such as antidepressants and treatments for schizophrenia.



The study evaluated a nationally representative survey of private health plans regarding mental health and substance abuse services. Most plans covered at least 2 antidepressants and at least 2 antipsychotic drugs at a medium copayment (averaging $21) that gave the physician some leeway in choosing the initial medication. However, in many plans patients who did not respond to one of those drugs faced a substantial hike in copayment (to an average of $38) in order to try a potentially more effective drug. Coverage of drugs for ADHD was more restrictive.







The study was funded by grants from the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse.



Contact: Laura Gardner


Brandeis University

Controlling ADHD

Attention deficit hyperactivity disorder (ADHD) is the most common behavioral disorder in children; it adversely affects performance in school and emotional development, and the symptoms can continue into adulthood.


Researchers at the Department of Nuclear Medicine, University of Munich, investigated a method to predict which ADHD patients will not respond to Ritalin therapy by measuring the degree to which [Tc?99m]TRODAT-1, a radiolabled protein, binds to the dopamine transporter. The study used single photon emission computed tomography (SPECT) to quantify the degree of binding. They delivered the results of their study on June 22 at the Society of Nuclear Medicine's 51st Annual Meeting in Philadelphia.


Ritalin works by blocking the dopamine transporter, increasing dopamine levels in the brain. But this treatment is often controversial because it can involve long-term drug therapy in children. Because 20%-30% of patients with ADHD do not respond to Ritalin therapy, a method of predicting therapeutic response would reduce exposure of ADHD patients to a drug that is unlikely to be effective.


Initial symptoms and post-therapy symptoms were measured in 18 adult ADHD patients using the Clinical Global Impressions (CGI) scale. Of the 13 patients who showed high levels of dopamine transporter binding, 12 demonstrated a significant improvement of ADHD symptoms on Ritalin. Conversely, none of the 5 patients who showed reduced levels of dopamine transporter binding responded to Ritalin therapy.


According to Dr. Christian la Fougere, the presenting author of the study, "Our results indicate that measurement of dopamine transporter may be an important prognostic predictor for therapeutic response to Ritalin."


Dr. la Fougere went on to speculate, "If we can determine who will respond to the drug and who will not respond, then only those patients who will benefit will be treated with Ritalin. Moreover, we can begin to examine alternative methods to treat the ADHD patients who do not respond to Ritalin."


The Society of Nuclear Medicine is holding its 51st Annual Meeting June 19-23, 2004, at the Pennsylvania Convention Center in downtown Philadelphia. Hot topics for the 2004 meeting include techniques for the early diagnosis of Alzheimer's disease; advanced imaging for the diagnosis, staging, and treatment of cancer; nuclear cardiology; and the collaboration between nuclear medicine and bioengineering in the fight against cancer.


Contact: Darren DiPatri



202-955-1242

Society of Nuclear Medicine


View drug information on Ritalin LA.

Consumer Reports To Parents: Think Twice About Free Prescription ADHD Drug Samples For Your Children

According to a new Consumer Reports Best Buy Drugs report, parents should be skeptical if their doctors offer them free prescription drug samples, especially for the treatment of attention deficit hyperactivity disorder (ADHD). Free samples can hook consumers on high-priced brand name drugs that are not any better or safer than less expensive generic medicines. In addition, when doctors give out free samples, they often fail to give patients information inserts that highlight important safety and side effect information.


Consumer Reports Best Buy Drugs found that two generic ADHD drugs, dextroamphetamine and methylphenidate, are as safe and effective as well- known drugs like Adderall XR, Concerta or Strattera. By switching to one of those two generic drugs, consumers could save roughly $3,000 a year off the retail price.


"Parents want to do what is best for their children," says Dr. John Santa, director of the Consumer Reports Health Ratings Center. "But free samples and clever advertising convince them they should be shelling out thousands of dollars a year for brand name prescription drugs when equally effective generics are available."


ADHD is one of the most common behavioral problems diagnosed among school-age children in the United States and about 7 percent (about 4.5 million in 2006) of children aged 4 to 17 have been diagnosed with the disorder. When ADHD needs to be treated with medication, parents may be presented with advertisements and free samples of expensive brand-name drugs.


Drug companies gave away an estimated $16 billion in free drug samples in 2004, and doctors routinely hand out these free samples to parents. In fact, according to one October 2008 study in the journal of Pediatrics; about 1 out of every 10 kids already taking a medication got a free drug sample. According to that study, which looked at data from 2004, the ADHD drug Strattera was the 4th most common free drug sample given to children; Adderall XR was in the top 15.


A recent poll by the Consumer Reports National Research Center revealed that 80 percent of Americans who take prescription drugs have received free samples from their physicians. "The use of free samples is extremely prevalent and insidious," said Santa. "And is likely not the best first-choice treatment for a patient's condition."


"Once the samples run out, consumers are likely to end up with sticker shock when they go to fill the prescription," explained Santa. Moreover, samples often do not contain a patient package insert, which describe important safety information.















Ensure a Correct ADHD Diagnosis


Consumer Reports Best Buy Drugs notes that many young patients who take ADHD drugs either do not have ADHD or have only mild symptoms. Before starting any drug treatment for ADHD, it's essential to get an accurate diagnosis by a medical professional.


"Few children present with symptoms of ADHD that can be easily diagnosed by simple observation," said Dr. Orly Avitzur, medical adviser, Consumers Union. "Most need to be evaluated with formal testing, and questionnaires answered by the parents and teachers. A complete history and physical examination should also be performed before medication is prescribed."


Children or teens with ADHD exhibit a persistent pattern, lasting six months or more, including impulsive behavior, hyperactivity, and/or lack of focus and inability to complete a task. A pediatrician, primary care doctor or mental-health professional should always begin by ruling out other possible reasons for their behavior. Parents should question a medical professional who diagnoses ADHD on the first visit and prescribes a drug on the spot.


ADHD Drugs May Only Work for a Few Years


And there is another hitch: a recent study shows that at least one ADHD stimulant drug, methylphenidate (Ritalin), may only work for a few years. There is little evidence proving a clear benefit beyond that. Long term studies have not been done on other ADHD drugs. Parents should routinely check in with their child's doctor about whether the drugs are still working since all stimulant drugs, along with Strattera (a non-stimulant), may have long-term risks, including possibly suppressing a child's growth and a rare risk of sudden death, stroke or heart attack.


Methodology


The Consumer Reports Best Buy Drugs report on drugs to treat ADHD is based on a systematic review of hundreds of research articles and studies, where the risks and benefits of one drug or many drugs against each other are evaluated. This kind of systematic review is known as comparative effectiveness and all Consumer Reports Best Buy Drugs reports use this process as the basis for their drug Ratings.


JULY 2009


(C) Consumers Union 2009. The material above is intended for legitimate news entities only; it may not be used for commercial or promotional purposes. Consumer Reports(R) is published by Consumers Union, an expert, independent nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. To achieve this mission, we test, inform, and protect. To maintain our independence and impartiality, Consumers Union accepts no outside advertising, no free test samples, and has no agenda other than the interests of consumers. Consumers Union supports itself through the sale of our information products and services, individual contributions, and a few noncommercial grants.


Source: Consumer Reports Health


View drug information on Adderall XR; Concerta; Ritalin LA.

Consistent, Managed Treatment Works Best For Children With AD/HD

According to the
recently released follow up study to the Multimodal Treatment Study on
Attention-Deficit/Hyperactivity Disorder (MTA) in the August issue of the
Journal of the American Academy of Child and Adolescent Psychiatry
(JAACAP), children and young people with AD/HD who received carefully
managed medication alone or in combination with behavioral management and
educational adaptations fared better than children who did not. However,
study participants who no longer received intensive interventions and
returned to standard community based care had lost the initial advantages
after three years.


These findings show highly intensive treatment works best when begun
early and consistently maintained. If high quality treatment is not
continued, the initial benefits may be lost several years later. Lead
researcher Peter Jensen, M.D., has emphasized the need for parents and
healthcare providers to work closely together for the benefit of the child
affected by AD/HD. Unfortunately, recent reports in the media have
misrepresented the MTA's findings and drawn unsubstantiated conclusions.



CHADD, Children and Adults with Attention-Deficit/Hyperactivity
Disorder, encourages each family to work with their healthcare providers
for the most effective treatment for their families and children affected
by AD/HD.


CHADD

chadd

Ability To Quit Smoking May Depend On A.D.H.D. Symptoms

Tobacco use is more prevalent and smoking cessation less likely among persons with Attention Deficit Hyperactivity Disorder (A.D.H.D.) In a study of smokers with attention deficit and hyperactivity symptoms, those who exhibited elevated hyperactivity and impulsivity, with or without inattention, showed lower quit rates after 8 weeks than those with inattention symptoms alone or those without the A.D.H.D. symptoms. The study, now available online in Nicotine and Tobacco Research, could help smokers and physicians to better tailor cessation treatment for individuals with A.D.H.D.


"Greater understanding of the divergent associations that exist between the different kinds of A.D.H.D. have important public health consequences for smoking cessation and decreased tobacco-related mortality in this population," said the study's lead author Lirio Covey, Ph.D., professor of clinical psychology (in psychiatry) at Columbia University Medical Center and the New York State Psychiatric Institute.


"The effect of A.D.H.D. by itself on smoking cessation has rarely been examined; the effects of the individual A.D.H.D. symptoms on smoking cessation, even less so. To our knowledge, the effects of inattention or hyperactivity at baseline as separate domains of A.D.H.D. on cessation treatment outcome have never been examined," Dr. Covey reported.


During the initial, eight-week phase of a maintenance treatment study, 583 adult smokers, 43 of whom were identified with clinically significant A.D.H.D. symptom subtypes using the A.D.H.D. Current Symptom Scale, were treated with the medication buproprion (brand name Zyban®), the nicotine patch and regular cessation counseling. Compared to smokers without A.D.H.D., smokers of both A.D.H.D. subtypes combined showed lower abstinence rates throughout the study.


Breakdown of the A.D.H.D. group by subtype, however, revealed a more complicated picture. The researchers found that by the end of the treatment, the proportion of abstainers among A.D.H.D. smokers with inattention were nearly identical to those without A.D.H.D. (55 percent compared to 54 percent, respectively).


By contrast, the A.D.H.D. subgroup with hyperactivity, with or without inattention, exhibited lower quit rates throughout the treatment period compared to smokers without A.D.H.D., essentially finding that only in the presence of hyperactivity and impulsivity, were differences observed between smokers with or without A.D.H.D. symptoms.


"The knowledge gained from further study of how these early onset disorders of nicotine dependency and A.D.H.D. are related could lead to early prevention of either one or both of these conditions," concluded Dr. Covey. More research is needed to tease out why hyperactivity causes less cessation success.















The greater propensity to smoke and difficulty quitting among persons with mental illness is thought to play a role in the "hardening" phenomenon, or the increased resistance to smoking cessation among certain smokers.


Much evidence that nicotine improves attentiveness and performance deficits among persons with A.D.H.D. provides a "self-medicating" rationale for tobacco use among persons with A.D.H.D. Pre-clinical data showing that dopamine, a neurotransmitter relevant to attentional processes and impulse control, is released upon smoking, is consistent with the self-medication hypothesis.


A.D.H.D. is a neuropsychiatric condition that begins in early childhood and, in most cases, persists to adolescence and adulthood. The core symptom domains in A.D.H.D. are inattention and hyperactivity/impulsivity. A.D.H.D. has been sub-classified into three subtypes: predominantly inattention, predominantly hyperactivity/impulsivity, and combined inattention and hyperactivity/impulsivity.


This study was supported by the National Institute on Drug Abuse (NIDA). In addition, study medications were donated by GlaxoSmithKline, Inc.


Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future health care leaders at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians and Surgeons was the first in the country to grant the M.D. degree. Among the most selective medical education institutions in the country, CUMC is home to the largest medical research enterprise in New York state and one of the largest in the United States. Visit cumc.columbia.


Columbia Psychiatry is ranked among the best departments and psychiatric research facilities in the nation and has contributed greatly to the understanding of and current treatment for psychiatric disorders including depression, suicide, schizophrenia, bipolar and anxiety disorders, and childhood psychiatric disorders. Located at the New York State Psychiatric Institute on the NewYork-Presbyterian Hospital/Columbia University Medical Center campus in the Washington Heights community of Upper Manhattan, the department enjoys a rich and productive collaborative relationship with physicians in various disciplines at Columbia University's College of Physician and Surgeons. Visit http://columbiapsychiatry.


Columbia University Medical Center

701 W 168th St., HHSC 206

New York

NY 10032

United States

cumc.columbia



View drug information on Zyban Sustained-Release Tablets.

Concerta(R) (methylphenidate HCl) Approved for the Treatment of ADHD in Adolescents, Canada

Health Canada has approved CONCERTA(R) (methylphenidate HCl) Extended-release Tablets for use in adolescents (aged 13 to 18) with Attention Deficit Hyperactivity Disorder (ADHD).1 Until now CONCERTA(R) was approved for the treatment of ADHD in children aged six to 12 years.


In a clinical study of adolescents aged 13 to 18 years, CONCERTA(R) at doses up to 72 mg significantly reduced ADHD symptoms, such as difficulty paying attention to schoolwork. 2


"ADHD causes impairments that can span over a child's or adolescent's life-time," says Dr. Declan Quinn, Royal University Hospital, University of Saskatchewan. "To give these children, and especially adolescents, a better chance in life and help them reach their full potential, a reliable treatment regimen including behavioural therapy and extended-release medication like CONCERTA(R) is important. An effective once a day dose schedule will help with compliance and is very important for the adolescent."


When children and adolescents with ADHD go untreated or are inadequately treated, they can be at risk for developing poor academic performance and poor social skills which can lead to more significant consequences later in life, including unemployment, criminal behaviour and substance misuse. 3,4


"One-dose-per-day medications such as CONCERTA(R) control symptoms of ADHD, take medication out of the classroom and minimize the 'ups and downs' in behaviour associated with multiple dosing, throughout the day," comments Dr. Martin Gignac, child psychiatrist at the Philippe Pinel Institute in Montreal.


In two CONCERTA(R) studies, namely one study with children where the ADHD comparator medication was given three times a day5 and the other, a placebo-controlled study with adolescents6, significantly more patients treated with once-a-day CONCERTA(R) responded to treatment and achieved remission (i.e., normalization of function) compared to patients on the comparator medication or placebo. In the study for children, remission rates were 44 percent for those on CONCERTA(R) compared to 16 percent for those on the three times a day comparator medication.7 This research suggests that CONCERTA(R) is associated with superior symptom control compared to older ADHD treatments.


About ADHD


Approximately four to 11 percent of school-aged children/adolescents are affected by ADHD which totals up to an estimated half million children/adolescents in Canada alone.8 ADHD is characterized by three core symptoms - inattention, hyperactivity and impulsivity. Inattention can include an inability to focus and pay attention or difficulty finishing tasks. The child is easily distracted. Hyperactivity can include fidgeting, talking excessively and a tendency to run around at inappropriate times or difficulty playing and engaging in leisure activities. Impulsivity can include difficulty awaiting turn and interrupting or intruding often on others.9















About CONCERTA(R)


CONCERTA(R) is a once-daily extended-release formulation of methylphenidate. The efficacy of CONCERTA(R) has been demonstrated in studies conducted in children and adolescents. Only a doctor can determine if medication is the right treatment for individuals with ADHD.


CONCERTA(R) uses an advanced OROS(R) extended-release delivery system to deliver a controlled rate of medication throughout the day. Because of its unique OROS(R) system, CONCERTA(R) minimizes the ups and downs in blood levels experienced with stimulant medications taken several times a day.


CONCERTA(R) should not be taken by patients with: significant anxiety, tension or agitation; allergies to methylphenidate or other ingredients in CONCERTA(R); glaucoma, Tourette's syndrome, tics or family history of Tourette's syndrome; current/recent use of monoamine oxidase inhibitors (MAOIs). Abuse of methylphenidate may lead to dependence. CONCERTA(R) should not be taken by children under six years of age.


In clinical studies with children using CONCERTA(R), the most common side effects were headache, stomach pain, sleeplessness and decreased appetite. In clinical studies with adolescents using CONCERTA(R), the most common side effects were headache, accidental injury and sleeplessness.


CONCERTA(R) is marketed by Janssen-Ortho Inc.


Janssen-Ortho Inc.


Janssen-Ortho Inc. is a brand-name pharmaceutical company headquartered in Toronto with a broad range of medications used in attention deficit hyperactivity disorder, psychiatry, neurology, pain management, women's health, infectious disease, gastroenterology and urology.


References:


1 CONCERTA(R) product monograph.


2 Ibid.


3 Barkley RA. Major life activity and health outcomes associated with attention-deficit/hyperactivity disorder. J Clin Psychiatry 2002; 63 (Suppl 12): 10-15.


4 Mannuzza S et al. Adult psychiatric status of hyperactive boys grown up. Am J. Psychiatry 1998; 155:493-498.


5 Steele M, Riccardelli R, Binder C. Effectiveness of OROS(R)-methylphenidate vs. usual care with immediate-release methylphenidate in ADHD children. Presented at the American Psychiatric Association annual meeting, May 1-6th, 2004, New York City, USA.


6 Spencer T. et al. OROS(R) Methyphenidate Treatment for Adolescent Attention-Deficit/Hyperactivity Disorder. Presented at 50th Anniversary Meeting of the American Academy of Child and Adolescent Psychiatry, Miami, FL, October 14-19, 2003.


7 Steele M, Riccardelli R, Binder C. Effectiveness of OROS(R)-methylphenidate vs. usual care with immediate-release methylphenidate in ADHD children. Presented at the American Psychiatric Association annual meeting, May 1-6th, 2004, New York City, USA.


8 Figures based on Statistics Canada 2004 population by sex and age and prevalence rates from Einarson TR, Iskedjian M. Novel Antipsychotics for Patients with Attention-Deficit Hyperactivity Disorder: A Systematic Review. Ottawa: Canadian Coordinating Office for Health Technology Assessment; 2001. Technology report no. 17.


9 American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Washington, D.C., American Psychiatric Association, 1995.


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