G.R.A.C.E. Study Will Examine Efficacy of Ritalin (R) LA in Female Adolescents Aged 12-17
EAST HANOVER, N.J., Aug. 26 (PRNewswire) — Novartis Pharmaceuticals Corporation announced today that it is conducting a new clinical study to evaluate the efficacy and safety of Ritalin (R) LA (methylphenidate HCl) extended release capsules in girls aged 12-17. The study is the first clinical trial to examine the effects of medication specifically in females with Attention-Deficit/Hyperactivity Disorder (ADHD). Known as G.R.A.C.E. (Girls, Ritalin LA, and ADHD: A Controlled Evaluation), the study is designed to evaluate the clinical effects of Ritalin LA vs. placebo in managing ADHD symptoms, social functioning (peer and family relationships), self-esteem, mood and school performance. Ritalin LA, the only long acting extended- release formulation of genuine Ritalin (R) (methylphenidate HCl), received U.S. Food and Drug Administration (FDA) marketing clearance in June 2002.
Compared to boys with ADHD, girls with ADHD frequently show less hyperactivity and aggression and are more likely to show symptoms consistent with the ADHD-inattentive subtype that are less easily noticed. Behaviors associated with the inattentive subtype include forgetfulness, difficulty listening and completing tasks, poor organization, and being highly distractible. Research suggests that children with the inattentive subtype of ADHD are accurately diagnosed only 50% of the time. Furthermore, several reports suggest that females with ADHD are more likely to internalize symptoms and manifest with anxiety, depression and low self-esteem than boys with the disorder. “Although there is a significant body of research in ADHD, the study of the disorder in females is just beginning. This trial is important because it will be the first to specifically examine the effects of ADHD treatment on girls’ ADHD symptoms, which can present differently than boys’,” said Scott West, M.D., President and CEO, CNS Healthcare and lead investigator of the study. “The initiation of the G.R.A.C.E. Study is an important step towards identifying and addressing the unique needs of this patient population.”
The 10-week, double-blind, placebo-controlled study will include more than 100 female patients who have been diagnosed with ADHD and will be conducted in 13 centers in the United States. All participants will be evaluated weekly to measure efficacy and tolerability. Efficacy will be evaluated using the Conners Parent Rating Scale (CPRS), a tool that assesses behavior in children and adolescents. Secondary efficacy assessment tools include the Conners- Wells’ Adolescent Self-Report Scale (CASS-S – a 27-item scale that closely parallels the parent rating scale, but is completed by study participants); the Piers-Harris Children’s Self-Concept Scale (PHCSCS-2 – a tool that assesses adolescents’ quality of life including health, schoolwork, social activities, behavior and family life); and the Clinical Global Impression Scales (CGI-S and CGI-C – standard assessment tools completed by the investigator). “This time of year, back-to-school, can be a particularly challenging time for adolescents with ADHD and these challenges are only exacerbated when children, parents and teachers do not know that it is ADHD that is causing the problem,” said Dr. West. “We hope that by bringing attention to the unique ways that ADHD manifests in girls we can help families appropriately address the difficulties caused by ADHD both in and out of the classroom.”
About ADHD and Females
ADHD is a neurobiologic disorder that interferes with an individual’s ability to regulate activity level and behavior, and sustain focus in developmentally appropriate ways. It is the most studied childhood psychiatric disorder and is supported by a substantial body of scientific evidence. Scientific research indicates that ADHD may be related to disturbances in the neurotransmission of dopamine and, to a lesser extent, norepinephrine. Research suggests that medications, such as Ritalin LA, enhance nerve-to-nerve communication by blocking the reuptake of both dopamine and norepinephrine. Without treatment, ADHD can have long-term effects on a child’s self-esteem and his or her ability to make friends and succeed in school or work.
A nationwide survey about gender differences in ADHD released in 2002, found that girls with ADHD face greater impairment in areas of social development including self-esteem, social relationships, and family relationships than boys with the disorder. Findings also suggest that gender has important implications for diagnosis and treatment of ADHD. The survey was conducted by Harris Interactive and sponsored by Novartis Pharmaceuticals Corporation.
