Washington Neuropsychological Institute Release: Preliminary Data Suggest ADDERALL XR(R) CII Significantly Improved Simulated Driving Performance In Young Adults With ADHD

SAN DIEGO, Nov. 19 /PRNewswire/ -- The Washington Neuropsychological Institute today announced that preliminary data suggested that ADDERALL XR (R) CII significantly improved simulated driving performance in young adults aged 19 to 25 years with attention-deficit/hyperactivity disorder (ADHD) for up to 12 hours after taking the medication, as compared with placebo. In addition, ADDERALL XR significantly improved ADHD symptom control of young adults with ADHD as compared with placebo. This preliminary, six-week, double-blind, placebo-controlled crossover study, led by Gary G. Kay, Ph.D., Washington Neuropsychological Institute, Washington, DC, was presented today at the 17th Annual U.S. Psychiatric & Mental Health Congress in San Diego, CA.

"The symptoms of ADHD can significantly affect a person's ability to focus and respond to changing conditions while driving, which can obviously have very serious consequences," said Dr. Gary Kay, Ph.D., president of the Washington Neuropsychological Institute. "Young adults with ADHD receive twice the number of traffic violations and have more license suspensions and revocations than their peers without ADHD. Records also show that people with ADHD were at fault in more car crashes and were involved in more severe car accidents than people without ADHD. This study provides us with important data demonstrating that ADDERALL XR can help young adults control their ADHD symptoms throughout a 12-hour day and therefore improve their ability to drive better and more safely."

The three main symptoms of ADHD include inattention, hyperactivity and impulsivity. Up to 65 percent of children with ADHD may still exhibit symptoms into adulthood. If left untreated, these symptoms may seriously and adversely affect patients as well as their families and friends. Over 8 million adults in the U.S. may exhibit symptoms of ADHD. Appropriate diagnosis and treatment of ADHD in adults helps improve self-esteem, work performance and skills, educational achievement and social competencies.

The Effect of ADDERALL XR Treatment on Driving Performance in Young Adults with ADHD (USPMHC Poster # 316)

This preliminary, six-week study suggested that patients taking ADDERALL XR demonstrated a significant improvement in driving performance compared to placebo, as measured by their Driving Safety Score (DSS), which was derived from safety related driving parameters using the STISIM Driving Simulator. In addition, the data revealed that ADDERALL XR significantly improved driving safety scores at 7 hours and 12 hours after taking medication. Patients taking ADDERALL XR also demonstrated a significant improvement in cognitive functioning compared to placebo, as assessed by the CogScreen-Aeromedical Edition (AE) Aviator Predictor Score (APS), which was derived from a computerized test developed for the Federal Aviation Administration to measure the cognitive functioning (e.g., multi-tasking ability, information processing, etc.) of pilots.

Furthermore, 80 percent of patients experienced a 30 percent reduction in their ADHD Rating Scale (ADHD-RS) score when taking ADDERALL XR, signifying an overall improvement in ADHD symptoms, while only 13 percent of patients achieved this level of symptom improvement when receiving placebo (P=0.0004).

About the Study

During the six-week study period, investigators randomized 19 patients aged 19 to 25 years to receive three weeks of active treatment with ADDERALL XR or treatment with placebo in a crossover design. All patients were diagnosed with ADHD using the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR(TM)) criteria. Doses of ADDERALL XR were administered as 20 milligrams (mg) for 1 week and investigational doses of 40 mg and 50 mg for the second and third weeks, respectively. At Week 3 of the double-blind treatment period, the group taking ADDERALL XR crossed over to receive three weeks of treatment with a placebo while the group taking a placebo crossed over to receive three weeks of active ADDERALL XR treatment.

Following a screening period, all patients were tested at a practice visit (testing visit 1) and after each three-week treatment period (testing visits 2 and 3). Simulated driving performance was measured by STISIM, a computer simulator with a wide field of view created by three 25-inch monitors, at 2, 7 and 12 hours after taking medication. The STISIM was designed to assess critical driving skills, including situation awareness, hazard perception, risk assessment and decision-making under time pressure.

In addition, cognitive functioning (e.g., multi-tasking ability, information processing, etc.) was assessed using the CogScreen-AE at hour 0, 3.5, 8.5, and 13.5 hours after medication after each three-week treatment period (testing visits 2 and 3).

The majority of side effects during the trial were mild or moderate and consistent with known side effects of stimulant medications. The most common side effects reported by patients taking ADDERALL XR during the trial included decreased appetite, weight loss, dry mouth, insomnia and bruxism (teeth grinding). The most common side effects reported by patients taking placebo during the trial included decreased weight and headache.

The study was supported by Shire Pharmaceutical Development Inc. About ADHD

Although there is no cure for ADHD, physicians and advocates are finding ways to help people with the condition learn to adapt to their school, home, social and work settings. ADHD usually can be successfully managed with a combination of treatments, such as medication and structured coping techniques. Psychostimulants, medications that stimulate areas of the brain that control attention, impulses, and self-regulation of behavior, remain among the most successful treatments for people with ADHD. In fact, at least 70 percent of children with ADHD respond positively to psychostimulants. Medication should be considered part of an overall multi-modal treatment plan for ADHD.

For further information on ADHD please visit http://www.adhdsupportcompany.com/, http://www.chadd.org/, or http://www.nmha.org/.

About Washington Neuropsychological Institute

The Washington Neuropsychological Institute (WNImail@aol.com) is a private, independent research organization that conducts clinical research trials and provides consulting services to government agencies and to the pharmaceutical industry. At their Northwest Washington, DC facility WNI has conducted studies on antihistamines, anticholinergics, memory enhancement drugs, jet lag remedies, head trauma, epilepsy, diabetes, Parkinson's Disease, Alzheimer's Disease, and ADHD. WNI is fully equipped to support Phase III and Phase IV clinical trials. The institute specializes in computer-based neurocognitive testing and driving simulation. In addition, professional staff members are frequent lecturers at national and international medical and scientific meetings.

USPMHC Presentation # 316, (Friday, November 19, 2004, 3:45 PM) "The Effect of Adderall XR Treatment on Driving Performance in Young Adults with ADHD." Kay, Gary, Ph.D.

Washington Neuropsychological Institute

CONTACT: Dr. Gary Kay of Washington Neuropsychological Institute,+1-202-256-5617; or Michelle McLeod, +1-212-601-8295, or Tegwyn Anderson,+1-212-601-8460, +1-917-865-7226 (on-site), both of Porter Novelli, forWashington Neuropsychological Institute

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