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Completed Phase 3 Interventional Results available

Safety and Efficacy of Cariprazine for Bipolar I Disorder

ClinicalTrials.gov ID: NCT01058668

Public ClinicalTrials.gov record NCT01058668. 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 7, 2026, 9:03 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 Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder

Study identification

NCT ID
NCT01058668
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Forest Laboratories
Industry
Enrollment
497 participants

Conditions and interventions

Interventions

  • Cariprazine Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
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
Jan 31, 2010
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011
Last update posted
Apr 11, 2017

2010 – 2011

United States locations

U.S. sites
23
U.S. states
17
U.S. cities
22
Facility City State ZIP Site status
Forest Investigative Site 018 Little Rock Arkansas 72211
Forest Investigative Site 012 Cerritos California 90703
Forest Investigative Site 010 Costa Mesa California 92626
Forest Investigative Site 005 Oceanside California 92056
Forest Investigative Site 023 San Diego California 92102
Forest Investigative Site 017 San Diego California 92103
Forest Investigative Site 024 Santa Ana California 92701
Forest Investigative Site 016 New Britain Connecticut 06050
Forest Investigative Site 007 Washington D.C. District of Columbia 20016
Forest Investigative Site 002 Kissimmee Florida 34741
Forest Investigative Site 003 Orlando Florida 32821
Forest Investigative Site 026 Atlanta Georgia 30308
Forest Investigative Site 013 Honolulu Hawaii 96813
Forest Investigative Site 011 Hoffman Estates Illinois 60169
Forest Investigative Site 021 Greenwood Indiana 46143
Forest Investigative Site 001 Shreveport Louisiana 71115
Forest Investigative Site 006 Rockville Maryland 20850
Forest Investigative Site 025 St Louis Missouri 63118
Forest Investigative Site 008 Cedarhurst New York 11516
Forest Investigative Site 019 Philadelphia Pennsylvania 19139
Forest Investigative Site 015 Memphis Tennessee 38119
Forest Investigative Site 004 Irving Texas 75062
Forest Investigative Site 014 Bothell Washington 98011

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 43 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01058668, 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 11, 2017 · Synced May 7, 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 NCT01058668 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →