Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD
Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
Summary
There is a scarcity of clinical trials assessing the effects of medications in children with
bipolar disorder. This study aims to assess the efficacy of Aripiprazole associated with
Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder
comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not
have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double
blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole
+ placebo. The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores
compared to aripiprazole + placebo.