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Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Long-term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder

NCT01059539•Forest Laboratories

Summary

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who have provided informed consent prior to any study specific procedures.
•Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
•Patients who experienced a manic or mixed episode that required treatment within the past 12 months.
•Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).

Exclusion Criteria

•Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder.

Locations (35)

Forest Investigative Site 015

Springdale, Arkansas, United States

Forest Investigative Site 010

Carson, California, United States

Forest Investigative Site 020

Cerritos, California, United States

Forest Investigative Site 009

Escondido, California, United States

Forest Investigative Site 004

Garden Grove, California, United States

Forest Investigative Site 016

San Diego, California, United States

Forest Investigative Site 007

Santa Ana, California, United States

Forest Investigative Site 023

Washington D.C., District of Columbia, United States

Forest Investigative Site 001

Bradenton, Florida, United States

Forest Investigative Site 006

Fort Lauderdale, Florida, United States

Key Dates

Start Date

February 28, 2010

Primary Completion Date

February 29, 2012

Completion Date

February 29, 2012

Last Updated

June 13, 2019

Enrollment

403

ACTUAL participants

Conditions

Bipolar I Disorder

Interventions

Cariprazine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

ERG Components in Schizophrenia and Bipolar Disorder Type I

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)