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Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression

NCT02670551•Forest Laboratories

View on ClinicalTrials.gov

Summary

This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 milligram (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for bipolar I disorder without psychotic features confirmed by the administration of the Mini International Neuropsychiatric Interview (MINI), with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration
•Currently treated as an outpatient at the time of enrollment
•A verified previous manic or mixed episode. Verification must include one of the following sources: --Treatment of mania with an anti-manic agent (eg, lithium or divalproate) or antipsychotic medication with an approved indication for mania --Hospital records/Medical records --Participant report corroborated by caretaker or previous or current treating clinician
•17-item Hamilton Depression Rating Scale (HAMD-17) total score ≥ 20
•HAMD-17 item 1 score ≥ 2
•Clinical Global Impressions-Severity (CGI-S) score ≥ 4
•Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test (women of childbearing potential only)
•Normal physical examination, clinical laboratory test results, and electrocardiogram (ECG) results or abnormal findings that are judged not clinically significant by the Principal Investigator (PI)

Exclusion Criteria

•Young Mania Rating Scale (YMRS) total score \> 12
•Four or more episodes of a mood disturbance (depression, mania, hypomania, or mixed state) within the 12 months before Visit 1
•Any current axis 1 psychiatric diagnosis other than bipolar disorder with the exception of specific phobias
•History of meeting DSM-5 criteria for: ○ Dementia, amnesic, or other cognitive disorder ○ Schizophrenia, schizoaffective, or other psychotic disorder
•○ Mental retardation - DSM-5-based diagnosis of borderline or antisocial personality disorder or other axis II disorder of sufficient severity to interfere with participation in this study
•History of meeting DSM-5 criteria for alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 6 months before Visit 1
•Positive result on blood alcohol test or urine drug screen for any prohibited medication. Exception: ○ Participants with a positive cannabinoid on entry may be retested before randomization. If the participant remains positive, the participant is no longer eligible ○ Participants positive for opiates on entry, discussion with Study Physician is required.
•Electroconvulsive therapy in the 3 months before Visit 1
•Previous lack of response to electroconvulsive therapy
•Treatment with a depot antipsychotic drug within 1 treatment cycle before Visit 1
+10 more criteria

Locations (74)

Arkansas Psychiatric Clinic Clinical Research Trials PA

Little Rock, Arkansas, United States

ATP Clinical Research, Inc.

Costa Mesa, California, United States

Synergy San Diego

Escondido, California, United States

Integrated Medical and Behavioral Associates

Glendale, California, United States

Apostle Clinical Trials, Inc.

Long Beach, California, United States

Pacific Research Partners, LLC

Oakland, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

Schuster Medical Research Institute

Sherman Oaks, California, United States

Viking Clinical Research

Temecula, California, United States

Pacific Clinical Research Medical Group

Upland, California, United States

Key Dates

Start Date

March 17, 2016

Primary Completion Date

July 19, 2017

Completion Date

July 19, 2017

Last Updated

January 30, 2019

Enrollment

488

ACTUAL participants

Conditions

Bipolar DisorderDepression

Interventions

Cariprazine

DRUG

Placebo

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: January 30, 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.

View ClinicalTrials.gov Terms and Conditions

Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression

Inclusion Criteria

Exclusion Criteria

ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics

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