Aripiprazole in the Treatment of Bipolar Depression

NCT ID: NCT00226317

Last Updated: 2017-04-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2008-02-29

Brief Summary

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A systematic open-label prospective pilot study to assess aripirazole for acute bipolar depression, with a secondary assessment of longer-term mood stabilization.

Detailed Description

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Study is 6 weeks long with 7 clinical visits.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aripiprazole in depression treatment

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

Interventions

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Aripiprazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* DSM-IV diagnosis of bipolar disorder, any subtype; MADRS \>16; MRS \< 10; not currently taking other mood stabilizers; women of reproductive potential must use an acceptable method of birth control

Exclusion Criteria

* Current substance abuse within past month; serious unstable medical condition; active suicidal ideation; pregnant, trying to become pregnant, or nursing; intent to continue or initiate herbal preparations
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Cambridge Health Alliance

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert T Dunn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cambridge Health Alliance

Locations

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Cambridge Health Alliance

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CHA-IRB-0030/01/04

Identifier Type: -

Identifier Source: org_study_id

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