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Completed Phase 3 Interventional Results available

Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

ClinicalTrials.gov ID: NCT01059539

Public ClinicalTrials.gov record NCT01059539. 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 Sep 13, 2026, 3:02 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 Long-term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.

Study identification

NCT ID
NCT01059539
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Forest Laboratories
Industry
Enrollment
403 participants

Conditions and interventions

Interventions

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
Feb 27, 2010
Primary completion
Feb 28, 2012
Completion
Feb 28, 2012
Last update posted
Jun 12, 2019

2010 – 2012

United States locations

U.S. sites
24
U.S. states
12
U.S. cities
23
Facility City State ZIP Site status
Forest Investigative Site 015 Springdale Arkansas 72764
Forest Investigative Site 010 Carson California 90746
Forest Investigative Site 020 Cerritos California 90703
Forest Investigative Site 009 Escondido California 92025
Forest Investigative Site 004 Garden Grove California 92845
Forest Investigative Site 016 San Diego California 92102
Forest Investigative Site 007 Santa Ana California 92701
Forest Investigative Site 023 Washington D.C. District of Columbia 20016
Forest Investigative Site 001 Bradenton Florida 34208
Forest Investigative Site 006 Fort Lauderdale Florida 33308
Forest Investigative Site 013 Kissimmee Florida 34741
Forest Investigative Site 021 Rockville Maryland 20850
Forest Investigative Site 024 Flowood Mississippi 39232
Forest Investigative Site 022 Creve Coeur Missouri 63141
Forest Investigative Site 003 Saint Charles Missouri 63301
Forest Investigative Site 025 St Louis Missouri 63118
Forest Investigative Site 012 Las Vegas Nevada 89102
Forest Investigative Site 002 Willingboro New Jersey 08046
Forest Investigative Site 005 Cincinnati Ohio 45219
Forest Investigative Site 011 Oklahoma City Oklahoma 73112
Forest Investigative Site 017 Austin Texas 78731
Forest Investigative Site 014 Austin Texas 78754
Forest Investigative Site 018 DeSoto Texas 75115
Forest Investigative Site 019 Houston Texas 77008

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 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01059539, 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 Jun 12, 2019 · Synced Sep 13, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01059539 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →