Aripiprazole in the Treatment of Bipolar Depression

Phase 4 Study: An Open Prospective Study of the Safety and Effectiveness of Aripiprazole in the Treatment of Bipolar Depression

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00226317

Enrollment

Registered

2005-09-27

Start date

2004-04-30

Completion date

2008-02-29

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Brief summary

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

Study is 6 weeks long with 7 clinical visits.

Interventions

DRUGAripiprazole

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Depression state	6 week study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026