Study of Aripiprazole in Patients With Acute Bipolar 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

NCT00097266

Enrollment

615

Registered

2004-11-22

Start date

2004-12-31

Completion date

2007-01-31

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 confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.

Interventions

DRUGPlacebo

Tablets/capsules, oral, 0 mg, once daily, 3 weeks (switched to arm B for an additional 9 weeks).

DRUGAripiprazole

Tablets, oral, 15-30 mg, once daily, 12 weeks.

DRUGHaloperidol

Capsule, oral, 5-15 mg, once daily, 12 weeks.

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

* Subjects with Bipolar I Disorder and a diagnosis of acute mania will be considered for this study.

Design outcomes

Primary

Measure	Time frame
Change in a mania rating scale at endpoint	—

Secondary

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

Countries

Bulgaria, Croatia, Mexico, Peru, Russia, South Africa, United States

Outcome results

None listed

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