Study of Aripiprazole in Patients With Bipolar I Disorder

Efficacy of Aripiprazole in Combination With Valproate or Lithium in the Treatment of Mania in Patients With Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00257972

Enrollment

400

Registered

2005-11-24

Start date

2004-10-31

Completion date

2007-12-31

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 Mania

Brief summary

The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

Interventions

DRUGaripiprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of bipolar I disorder, manic or mixed episode

Exclusion criteria

* First manic or mixed episode * Allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole * Participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole

Design outcomes

Primary

Measure	Time frame
Change from baseline to endpoint in a mania rating scale	—

Secondary

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

Countries

Australia, Bulgaria, Czechia, Estonia, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Russia, South Africa, Spain, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026