A new study in children aged 6 to 12 years of dasotraline, a promising new treatment for attention deficit hyperactivity disorder (ADHD), showed significant improvement in efficacy in the treatment of ADHD compared to placebo beginning at week 1 and continuing throughout the study. A detailed description of the trial design and the results is published in the Journal of Child and Adolescent Psychopharmacology, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers.
Robert Goldman, PhD, Sunovion Pharmaceuticals (Marlborough, MA and Fort Lee, NJ), and colleagues from Kennedy Krieger Institute/Johns Hopkins University (Baltimore, MD), New York University Langone Medical Center (New York, NY), and Massachusetts General Hospital (Boston, MA) coauthored the article entitled "Dasotraline in Children with Attention-Deficit/Hyperactivity Disorder: A Six-Week, Placebo-Controlled, Fixed-Dose Trial."
The researchers conducted a 6-week trial in which children with a diagnosis of ADHD received a once-daily morning dose of dasotraline (2 mg or 4 mg) or placebo. The primary endpoint to determine efficacy was an ADHD rating scale that determined change from baseline. Treatment with dasotraline 4g/day only was associated with significant improvement in efficacy. Dasotraline also showed significant improvement for some secondary efficacy endpoints, including measures of hyperactivity and inattentiveness. The study also assessed the safety of dasotraline treatment and performed subgroup analysis to look for differences in safety and efficacy across subgroups such as age, gender, and use of other treatments for ADHD.
"Over four million children suffer from ADHD. The investigation of new, safe treatments with less side effects is needed for this patient group," says Harold S. Koplewicz, MD, Editor-in-Chief of the Journal of Child and Adolescent Psychopharmacology and President of the Child Mind Institute in New York.