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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00080314

Enrollment

400

Registered

2004-03-30

Start date

2004-01-31

Completion date

2006-10-31

Last updated

2013-11-11

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

Conditions

Bipolar Disorder

Keywords

Bipolar 1 Disorder, depressed

Brief summary

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

Interventions

DRUGAripiprazole

Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* ages 18-65 * Men and women, who have experienced a prior manic episode that required hospitalization, and now meet criteria for a major depressive episode.

Design outcomes

Primary

Measure	Time frame
Change on a depression rating scale at endpoint	—

Secondary

Measure	Time frame
Response rate and Clinical Global Impression scale at endpoint	—

Countries

United States

Outcome results

None listed

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