The primary objective of the exploratory study was to compare the effects of two doses of eltoprazine with placebo in a cross-over design on the symptoms of attention deficit/ hyperactivity disorder (ADHD) in adults using the total scores from the ADHD Rating Scale-Version IV.
The compound achieved a reduction in the ADHD-RS-IV total score of 42% from baseline compared to placebo (p<0.051). Inattention (p< 0.041) and hyperactivity (p<0.047) were also significantly reduced when compared to placebo. Improvement was also observed in the clinical global impression-improvement assessment with a significant decrease in the overall severity of symptoms (p<0.03). Further analysis showed that a subset of patients, who shared higher screening and baseline scores at the beginning of the study, exhibited an even greater response to treatment in the ADHD-RS-IV total score (p<0.029). Based on these results, PsychoGenics plans to initiate further Phase-II studies in adults and children with ADHD. Sharon Wigal, director of clinical trials at University of California, Irvine Child Development Center, said: "The responses observed in this clinical trial are promising, and clearly indicate that eltoprazine is worthy of further study."