Aripiprazole in Patients With Acute Mania

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of Aripiprazole Monotherapy in the Treatment of Acutely Manic Patients With Bipolar I Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00095511

Enrollment

615

Registered

2004-11-08

Start date

2004-06-30

Completion date

2007-05-31

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 Mania

Brief summary

The purpose of this trial is to test the safety & efficacy of aripiprazole in patients with Bipolar Mania for a period of at least 12 weeks.

Interventions

DRUGaripiprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Primary diagnosis of Acute Bipolar I Mania

Exclusion criteria

* Patients with a DSM-IV diagnosis other than Bipolar I Mania

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

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026