Efficacy of a Novel Biphasic Controlled-Release Methylphenidate Formula in Adults With Attention-Deficit/Hyperactivity Disorder

• DOI: 10.4088/jcp.v68n0213
• Publication Date: 2009-10-27T16:24:25Z
• Authors: Umesh Jain; Lily Hechtman; Margaret Weiss; Tahira S. Ahmed; Joseph L. Reiz; Graeme A. E. Donn...; Zoltan Harsanyi; Andrew C. Darke
• Keywords: Crossover study

Article Abstract Objective: To evaluate the efficacy and safety of a new biphasic multilayer-release (MLR) methylphenidate formulation in double-blind, placebo-controlled crossover study adults with attention-deficit/hyperactivity disorder (ADHD). Method: Adults 18 to 60 years age DSM-IV diagnosis ADHD entered no-medication baseline week were then randomly assigned once-daily MLR or matching placebo. Patients titrated optimal effect over 1 3 weeks followed by 2 treatment on stable dose. The same titration protocol was repeated alternate treatment. Clinical Global Impressions scale (CGI) Conners†Adult Rating Scales (Self-rated, CAARS-S, Observer-rated, CAARS-O) collected at weekly clinic visits. conducted between October 2003 April 2004. Results: Fifty patients treatment, 39 analyzed per-protocol population (23 men, 16 women; mean = 37.9 years). CGI-Improvement scores subjects taking significantly improved compared placebo (Global Improvement: 2.6 vs. 3.7; p .0015). produced improvements Index T CAARS-S (12.2 5.4 ; .0083) CAARS-O (10.9 6.6 .1404). most frequent adverse events for headache (26% 24%, respectively), anorexia (22% 6%), insomnia 8%), nervousness (20% 4%), nausea (16% 8%). There no serious events. Conclusions: Once-daily produces significant symptoms situational behavior adult ADHD, prolonged duration minimal side effects, thus having potential improve compliance and, therefore, outcomes routine clinical use.