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

NCT ID: NCT00338273

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-11-30

Brief Summary

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

Detailed Description

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Conditions

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Bipolar Disorder

Keywords

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Bipolar I disorder with major depressive episode

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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A1

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.

A2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Aripiprazole

Tablets, Oral, 5 - 30 mg, Once daily, 8 weeks.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Abilify

Eligibility Criteria

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Inclusion Criteria

* Outpatients
* Must sign informed consent prior to protocol-related procedures

Exclusion Criteria

* Women who are pregnant, trying to become pregnant, or nursing
* Significant risk of committing suicide
* Any serious unstable medical conditions
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Local Institution

Durham, North Carolina, United States

Site Status

Local Institution

Ahmedabad, Gujarat, India

Site Status

Local Institution

Chennai, , India

Site Status

Local Institution

Delhi, , India

Site Status

Local Institution

Hyderabad, , India

Site Status

Local Institution

Lucknow, , India

Site Status

Local Institution

Mumbai, , India

Site Status

Local Institution

Visakhapatnam, , India

Site Status

Countries

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United States India

Other Identifiers

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CN138-149

Identifier Type: -

Identifier Source: org_study_id