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A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode

NCT00094432 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2013-11-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate several doses of aripiprazole in patients with bipolar depression.

Conditions

Interventions

DRUG

Aripiprazole

Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.

DRUG

Placebo

Tablets, Oral, 0 mg, Once daily, 8 weeks.

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
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00094432 on ClinicalTrials.gov