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

Not Applicable

Completed

• Conditions: Bipolar Disorder; Attention Deficit Hyperactivity Disorder

• Registration Number: NCT00116259
• Lead Sponsor: Federal University of Rio Grande do Sul

Brief 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

Detailed Description

Bipolar disorder (BD) is a chronic disorder that severely affects the normal development of children and adolescents. The disorder is associated with high rates of suicide tentative and high-risk behaviors like sexual promiscuity and drug abuse. Bipolar disorder in children is also associated with high rates of comorbidity, especially with Attention-Deficit Hyperactivity Disorder (ADHD). There is a scarcity of clinical trials assessing the effects of medications in children with BD. Moreover, the frequent presence of comorbid ADHD might determine lower response to treatment. Aripiprazole is a novel anti-psychotic drug. Its mechanism of action seems to be related to a stabilization of dopaminergic transmission, acting as a partial agonist especially in dopaminergic D2 receptors. It also has effects in 5-HT1a serotonergic receptors. Thus, it might have a promising effect in children and adolescents with comorbid BD and ADHD. A retrospective chart review, recently published, suggests the efficacy of this drug in children with BD. This study aims to assess the efficacy of Aripiprazole (a novel anti-psychotic drug) for the treatment of 50 children and adolescents (age range: 08 to 17 years-old) with Bipolar Disorder comorbid with ADHD. The study design is an 6-week randomized, double blind, parallel group trial. Patients were randomized to either aripiprazole or placebo. The hypotheses are: 1) Aripiprazole will significantly reduce maniac scores compared to placebo; 2)Aripiprazole will significantly reduce ADHD scores compared to placebo; 3) Aripiprazole will not be significantly associated to weight gain compared to placebo.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-06-27
• Study First Submitted QC: 2005-06-27
• Study First Posted: 2005-06-28
• Primary Completion: 2008-01
• Study Completion: 2008-02
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-06
• Last Update Posted: 2008-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age: 8-17
• BD type I or II comorbid with ADHD
• Baseline score in the YMRS > or = 20

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Scores in the Young Mania Rating Scale (BD)
Scores in the SNAP-IV (ADHD)
Weight

Secondary Outcome Measures

Name	Time	Method
Scores in the CDRS
Scores in the CMRS-P
Scores in CGI
Scores in the Kutcher Adolescent Depression Scale
Scores of quality of life (YQOL-R)
Report of side events

Trial Locations

Locations (1)

ADHD outpatient program; 🇧🇷 Porto Alegre - Brazil, RS, Brazil