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

NCT00116259 | Completed

• 1 other identifier: GPPG03-325a
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.Aripiprazole will significantly reduce maniac scores compared to placebo
2. 2.Aripiprazole will significantly reduce ADHD scores compared to placebo

Conditions

Bipolar Disorder; Attention Deficit Hyperactivity Disorder

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Scores in the Young Mania Rating Scale (BD)

• Scores in the SNAP-IV (ADHD)

• Weight

Secondary Outcomes (6)

• 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)

Interventions

Aripiprazole DRUG

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Hospital de Clinicas de Porto Alegre: collaborator

Study Sites (1)

ADHD outpatient program

Porto Alegre - Brazil, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (2)

• 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.

  PMID: 15685125 BACKGROUND

• 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.

  PMID: 19389329 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Attention Deficit Disorder with Hyperactivity

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Luis A Rohde, MD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2005
• First Posted: June 28, 2005
• Study Start: March 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 7, 2008

Record last verified: 2008-08

Locations

BR (1)