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Aripiprazole Associated With Methylphenidate in Children and Adolescents With Bipolar Disorder and ADHD

NCT00305370 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

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 associated with Methylphenidate (MPH)for the treatment of children and adolescents with bipolar disorder comorbid with ADHD who improve in maniac symptoms while receiving aripiprazole but did not have an adequate response in ADHD symptoms. The study design is a 4-week randomized, double blind, cross-over group trial. Patients were randomized to aripiprazole + MPH or aripiprazole + placebo. The main hypothesis is: Aripiprazole + MPH will significantly reduce ADHD scores compared to aripiprazole + placebo.

Conditions

Interventions

DRUG

Aripiprazole

Sponsors & Collaborators

  • 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
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-01-31
Completion
2008-03-31

Countries

  • Brazil

Study Locations

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 NCT00305370 on ClinicalTrials.gov