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. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00094432

Enrollment

650

Registered

2004-10-19

Start date

2004-06-30

Completion date

2006-11-30

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 I Disorder

Keywords

depressed

Brief summary

The purpose of this study is to evaluate several doses of aripiprazole 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

* Men and women, ages 18-65 * Have experienced a prior manic episode that required treatment with a mood stabilizer or antipsychotic, and now meet criteria for a major depressive episode.

Design outcomes

Primary

Measure	Time frame
Mean change from baseline to endpoint on the MADRS total score.	—

Secondary

Measure	Time frame
Clinical Global Impression - Bipolar Version	—
Severity of illness score depression	—
Mean change from baseline to endpoint	—

Countries

United States

Outcome results

None listed

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