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Completed Phase 3 Interventional Results available

Safety and Efficacy of Cariprazine for Bipolar I Disorder

ClinicalTrials.gov ID: NCT01058668

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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT01058668. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 14, 2026, 11:00 PM EST

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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

Brief summary

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

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes 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

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 2010 (Type not available)
Primary completion
Dec 2011 (Actual)
Completion
Dec 2011 (Actual)
Last update posted
Apr 12, 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 12, 2017 · Synced Nov 14, 2026

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