ClinicalTrials.gov record
Completed Phase 4 Interventional Results available

A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

ClinicalTrials.gov ID: NCT00261443

Public ClinicalTrials.gov record NCT00261443. 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 17, 2026, 8:33 PM EDT

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

Official title

Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy

Study identification

NCT ID
NCT00261443
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
Enrollment
1,270 participants

Conditions and interventions

Interventions

  • Lithium or Valproate with Aripiprazole Drug
  • Lithium or Valproate with placebo (PBO) 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
Aug 31, 2005
Primary completion
May 31, 2009
Completion
Sep 30, 2009
Last update posted
Apr 17, 2023

2005 – 2009

United States locations

U.S. sites
29
U.S. states
14
U.S. cities
27
Facility City State ZIP Site status
Tuscaloosa Va Medical Center Tuscaloosa Alabama 35404
Pravin Kansagra, M.D. Anaheim California 92801
Psychopharmacology Research Network Of Torrance Cerritos California 90703
Atp Clinical Research, Inc. Costa Mesa California 92626
Us Clinical Research Centers, Llc Costa Mesa California 92627
Va Long Beach Healthcare System Long Beach California 90822
Synergy Clinical Research Center National City California 91950
University Of California, Irvine Medical Center Orange California 92868
Clinical Neuroscience Solutions, Inc. Orlando Florida 32806
University Of South Florida Tampa Florida 33613
Carman Research Smyrna Georgia 30080
University Of Massachusetts Medical School Worcester Massachusetts 01605
Psych Care Consultants Research St Louis Missouri 63128
Cns Research Institute, P.C. Clementon New Jersey 08021
Neuropsychiatric Research Associates New York New York 10128
Behavioral Medical Research Of Staten Island Staten Island New York 10305
Richmond Behavioral Associates Staten Island New York 10312
Psychiatry And Clinical Research Raleigh North Carolina 27609
Rakesh Ranjan, Md & Associates, Inc. Beachwood Ohio 44122
University Of Cincinnati Medical Center Cincinnati Ohio 45267
Metro Health Medical Center Cleveland Ohio 44109
Midwest Clinical Research Center Dayton Ohio 45408
Portland Va Medical Center Portland Oregon 97201
Senior Adults Specialty Research, Inc. Austin Texas 78757
Futuresearch Trials Dallas Texas 75231
Insite Clinical Research DeSoto Texas 75115
Red Oak Psychiatry Associates, Pa Houston Texas 77090
University Of Utah School Of Medicine Salt Lake City Utah 84132
Northwest Clinical Research Center Bellevue Washington 98004

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 54 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00261443, 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 Apr 17, 2023 · Synced May 17, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00261443 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →