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

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00338273

Enrollment

Registered

2006-06-20

Start date

2006-12-31

Completion date

2007-11-30

Last updated

2013-11-08

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

Conditions

Bipolar Disorder

Keywords

Bipolar I disorder with major depressive episode

Brief summary

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

Interventions

DRUGAripiprazole

Tablets, Oral, 5 - 30 mg, 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

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Mean change from baseline to endpoint (Week 8 last observation carried forward = LOCF) on the Montgomery-Asberg Depression Rating Scale (MADRS) total score	—

Secondary

Measure	Time frame
Mean change from baseline to endpoint on the Clinical Global Impression-Bipolar Version, severity of illness score (depression)	—

Countries

India, United States

Outcome results

None listed

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