Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of Rio Grande do Sul
• Treatments: Aripiprazole; Methylphenidate

Criteria

Inclusion Criteria:

• Age: 8 -17

• BD type I or II comorbid with ADHD

• Reduction of maniac symptoms (30% reduction in the YMRS scores and/or CGI scores ≤ 2)while using aripiprazole during a previous study (NCT00116259)without improvement of ADHD symptoms (reduction in ADHD symptoms < 30% in the SNAP-IV). Those receiving placebo in the previous protocol will receive a 6- week open label treatment with aripiprazole. The same threshold for reducing maniac symptoms and absence of response in ADHD symptoms will be used.

Exclusion Criteria:

• IQ < 70

• Pregnancy or absence of a contraceptive method in fertile girls

• Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency

• Risk of suicide or homicide

• Clinical condition that might interfere in the study

• Known sensibility to aripiprazole