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Completed Phase 3 Interventional

Study of Aripiprazole in Patients With Acute Bipolar Mania

ClinicalTrials.gov ID: NCT00097266

Public ClinicalTrials.gov record NCT00097266. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 6, 2026, 12:53 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT00097266
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
615 participants

Conditions and interventions

Interventions

  • Aripiprazole Drug
  • Haloperidol Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2004
Primary completion
Dec 31, 2006
Completion
Dec 31, 2006
Last update posted
Nov 7, 2013

2004 – 2007

United States locations

U.S. sites
15
U.S. states
8
U.S. cities
15
Facility City State ZIP Site status
Local Institution Anaheim California
Local Institution Cerritos California
Local Institution Garden Grove California
Local Institution National City California
Local Institution Pico Rivera California
Local Institution Riverside California
Local Institution San Diego California
Local Institution Washington D.C. District of Columbia
Local Institution Maitland Florida
Local Institution Tampa Florida
Local Institution Shreveport Louisiana
Local Institution Albuquerque New Mexico
Local Institution Cleveland Ohio
Local Institution Oklahoma City Oklahoma
Local Institution DeSoto Texas

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00097266, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 7, 2013 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00097266 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →