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Study of Aripiprazole in Patients With Bipolar I Disorder

NCT00257972 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2013-11-08

No results posted yet for this study

Summary

The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

Conditions

Interventions

DRUG

aripiprazole

Sponsors & Collaborators

  • Otsuka America Pharmaceutical

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States
  • Australia
  • Bulgaria
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Russia
  • South Africa
  • Spain
  • Switzerland
  • United Kingdom

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 NCT00257972 on ClinicalTrials.gov