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

NCT00338273 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-11-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate flexible doses (5-30 mg) of aripiprazole in patients with bipolar depression.

Conditions

Interventions

DRUG

Aripiprazole

Tablets, Oral, 5 - 30 mg, 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

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
2006-12-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States
  • India

Study Locations

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Entities

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 NCT00338273 on ClinicalTrials.gov