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

NCT00116259 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-08-07

No results posted yet for this study

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

Conditions

Interventions

DRUG

Aripiprazole

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    collaborator OTHER

  • Federal University of Rio Grande do Sul

    lead OTHER

Principal Investigators

  • Luis A Rohde, MD · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2008-01-31
Completion
2008-02-29

Countries

  • Brazil

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00116259 on ClinicalTrials.gov