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

This study has been completed.
Sponsor:
Collaborator:
Hospital de Clinicas de Porto Alegre
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00116259
First received: June 27, 2005
Last updated: August 6, 2008
Last verified: August 2008
History of Changes
  Purpose

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

Condition Intervention
Bipolar Disorder
Attention Deficit Hyperactivity Disorder
 Drug: Aripiprazole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Aripiprazole in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Double Blind Placebo Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Scores in the Young Mania Rating Scale (BD)
  • Scores in the SNAP-IV (ADHD)
  • Weight

Secondary Outcome Measures:
  • Scores in the CMRS-P
  • Scores in CGI
  • Scores in the CDRS
  • Scores in the Kutcher Adolescent Depression Scale
  • Scores of quality of life (YQOL-R)
  • Report of side events

Estimated Enrollment: 50
Study Start Date: March 2005
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116259

Locations
Brazil
ADHD outpatient program
Porto Alegre - Brazil, RS, Brazil, 90035-003
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Luis A Rohde, MD Federal University of Rio Grande do Sul
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00116259     History of Changes
Other Study ID Numbers: GPPG03-325a, GPPG03-325a
Study First Received: June 27, 2005
Last Updated: August 6, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:
clinical trial
aripiprazole
Bipolar Disorder
Attention-Deficit Hyperactivity Disorder
ADHD

Additional relevant MeSH terms:
Bipolar Disorder
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 18, 2013