Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 27, 2005
August 6, 2008
March 2005
January 2008   (final data collection date for primary outcome measure)
  • Scores in the Young Mania Rating Scale (BD)
  • Scores in the SNAP-IV (ADHD)
  • Weight
Same as current
Complete list of historical versions of study NCT00116259 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Aripiprazole in Children and Adolescents With Bipolar Disorder and Attention Deficit Hyperactivity Disorder (ADHD)
Aripiprazole in Children and Adolescents With Bipolar Disorder and ADHD: A Randomized Double Blind Placebo Controlled Trial

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Bipolar Disorder
  • Attention Deficit Hyperactivity Disorder
Drug: Aripiprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
8 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00116259
GPPG03-325a, GPPG03-325a
Not Provided
Not Provided
Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Principal Investigator: Luis A Rohde, MD Federal University of Rio Grande do Sul
Federal University of Rio Grande do Sul
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP