Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)

• Status: Completed
• Trial end date: 2008-02-01
• 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 (a novel anti-psychotic drug) for the treatment of children and adolescents with bipolar disorder comorbid with ADHD. The study design is a 8-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo.

The main hypotheses are:

1. Aripiprazole will significantly reduce maniac scores compared to placebo

2. Aripiprazole will significantly reduce ADHD scores compared to placebo

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of Rio Grande do Sul
• Collaborator: Hospital de Clinicas de Porto Alegre
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• Age: 8-17

• BD type I or II comorbid with ADHD

• Baseline score in the YMRS > or = 20

Exclusion Criteria:

• IQ < 70

• Pharmacologic treatment in the last month

• 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