Aripiprazole in the Treatment of Bipolar Depression

Cambridge Health Alliance

Status: Completed

Conditions: Bipolar Disorder

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00226317

CHA-IRB-0030/01/04

Details and patient eligibility

About

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

Full description

Study is 6 weeks long with 7 clinical visits.

Enrollment: 20 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Aripiprazole in depression treatment

Experimental group

Treatment:

Drug: Aripiprazole