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

NCT ID: NCT00116259

Last Updated: 2008-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-02-29

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.

Conditions

Bipolar Disorder; Attention Deficit Hyperactivity Disorder

Keywords

clinical trial; aripiprazole; Bipolar Disorder; Attention-Deficit Hyperactivity Disorder; ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Aripiprazole

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: collaborator

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: lead

Principal Investigators

Luis A Rohde, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

ADHD outpatient program

Porto Alegre - Brazil, Rio Grande do Sul, Brazil

Countries

Brazil

References

Biederman J, McDonnell MA, Wozniak J, Spencer T, Aleardi M, Falzone R, Mick E. Aripiprazole in the treatment of pediatric bipolar disorder: a systematic chart review. CNS Spectr. 2005 Feb;10(2):141-8. doi: 10.1017/s1092852900019489.

Reference Type: BACKGROUND

PMID: 15685125 (View on PubMed)

Tramontina S, Zeni CP, Ketzer CR, Pheula GF, Narvaez J, Rohde LA. Aripiprazole in children and adolescents with bipolar disorder comorbid with attention-deficit/hyperactivity disorder: a pilot randomized clinical trial. J Clin Psychiatry. 2009 Apr 21;70(5):756-64. doi: 10.4088/JCP.08m04726.

Reference Type: DERIVED

PMID: 19389329 (View on PubMed)

Other Identifiers

GPPG03-325a

Identifier Type: -

Identifier Source: secondary_id

GPPG03-325a

Identifier Type: -

Identifier Source: org_study_id