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

January 10, 2019 updated by: Forest Laboratories

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
488

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD
      • Kardzhali, Bulgaria, 6600
        • SPH - Kardzhali, EOOD
      • Kazanlak, Bulgaria, 6100
        • MHAT "Dr. Hristo Stambolski", EOOD
      • Lovech, Bulgaria, 5500
        • State Psychiatric Hospital - Lovech
      • Pleven, Bulgaria, 5800
        • UMHAT 'Dr. Georgi Stranski', EAD
      • Plovdiv, Bulgaria, 4000
        • UMHAT "Sv. Georgi", EAD
      • Ruse, Bulgaria, 7003
        • MHC - Ruse, EOOD
      • Sofia, Bulgaria, 1431
        • UMHAT "Alexandrovska" EAD
      • Sofia, Bulgaria, 1113
        • MHATNP "Sv.Naum", EAD
      • Sofia, Bulgaria, 1606
        • Military Medical Academy - MHAT - Sofia
      • Sofia, Bulgaria, 1632
        • Medical Centre "Doverie" AD
      • Targovishte, Bulgaria, 7700
        • MHAT-Targovishte, AD
      • Varna, Bulgaria, 9020
        • DCC "Mladost M" - Varna, OOD
  • Estonia
      • Tallinn, Estonia, 10617
        • Marienthal Center of Psychiatry and Psychology
      • Tallinn, Estonia, 13517
        • West Tallinn Central Hospital
      • Tartu, Estonia, 50417
        • Tartu University Hospital
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
      • Kaunas, Lithuania, 44279
        • Romuvos klinika, UAB
      • Kaunas, Lithuania, 50185
        • Neuromeda, JSC
      • Kaunas, Lithuania, 53136
        • Republican Kaunas Hospital Psychiatry Clinic Mariu Division, Public Institution
      • Vilnius, Lithuania, 10204
        • 232Antakalnis Psychiatric Consultation Center, Public Institution
  • Poland
      • Białystok, Poland, 15-756
        • Podlaskie Centrum Psychogeriatrii
      • Bydgoszcz, Poland, 85-080
        • Przychodnia Srodmiescie Sp. z o. o.
      • Gdańsk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Leszno, Poland, 64-100
        • Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
      • Lublin, Poland, 20-045
        • Clinical Best Solutions
      • Lublin, Poland, 20-442
        • Specjalistyczna Praktyka Lekarska Marek Domanski
      • Pruszcz Gdański, Poland, 83-000
        • NZOZ Syntonia
      • Toruń, Poland, 87-100
        • Torunskie Centrum Psychiatrii Neuromed
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • INSPIRA Clinical Research
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Psychiatric Clinic Clinical Research Trials PA
    • California
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research, Inc.
      • Escondido, California, United States, 92025
        • Synergy San Diego
      • Glendale, California, United States, 91204
        • Integrated Medical and Behavioral Associates
      • Long Beach, California, United States, 90813
        • Apostle Clinical Trials, Inc.
      • Oakland, California, United States, 94612
        • Pacific Research Partners, LLC
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • Sherman Oaks, California, United States, 91403
        • Schuster Medical Research Institute
      • Temecula, California, United States, 92591
        • Viking Clinical Research
      • Upland, California, United States, 91786
        • Pacific Clinical Research Medical Group
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Comprehensive Psychiatric Care
    • Florida
      • Jacksonville, Florida, United States, 32256
        • CNS Healthcare
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions, Inc
      • Tampa, Florida, United States, 33609
        • Olympian Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Radiant Research
      • Decatur, Georgia, United States, 30030
        • iResearch Atlanta, LLC
      • Marietta, Georgia, United States, 30060
        • Northwest Behavioral Research Center
      • Smyrna, Georgia, United States, 30080
        • Carman Research
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Psychiatric Medicine Associates, L.L.C
      • Winfield, Illinois, United States, 60190
        • Neuroscience Research Institute Inc.
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • St. Charles Psychiatric Associates - Midwest Research Group
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Altea Research Institute
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc.
      • New York, New York, United States, 10023
        • Medical & Behavioral Health Research, PC
    • Ohio
      • Canton, Ohio, United States, 44718
        • Neuro-Behavioral Clinical Research
      • Cincinnati, Ohio, United States, 45215
        • Patient Priority Clinical Sites
      • Columbus, Ohio, United States, 43210
        • Ohio State University Department of Psychiatry
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
      • Oklahoma City, Oklahoma, United States, 73112
        • Sooner Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97214
        • Oregon Center for Clinical Investigations, Inc.
      • Salem, Oregon, United States, 97301
        • Oregon Center for Clinical Investigations
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Center For Clinical Research
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Lincoln Research, LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions
    • Texas
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry Associates, PA
      • Houston, Texas, United States, 77098
        • Houston Clinical Trials, LLC
      • Plano, Texas, United States, 75093
        • Research Across America
      • The Woodlands, Texas, United States, 77381
        • Family Psychiatry of The Woodlands
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Alliance Research Group
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Kirkland, Washington, United States, 98033
        • Core Clinical Research
      • Seattle, Washington, United States, 98104
        • Summit Research Network Seattle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Treatment with clozapine in a dose of > 50 mg/day in the past 2 years
  • Prior participation in any investigational study of RGH-188 or cariprazine within the past 12 months
  • Previous treatment with vagus nerve stimulation or transcranial magnetic stimulation within 6 months before Visit 1
  • Prior participation with any clinical trials, involving experimental or investigational drugs, within 6 months before Visit 1 or during the study
  • Initiation or termination of psychotherapy for depression within the 3 months preceding Visit 1, or plans to initiate, terminate, or change such therapy during the course of the study.
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Gastric bypass or any condition that would be expected to affect drug absorption (lap band procedures are acceptable if there is no problem with absorption)
  • Known history of cataracts or retinal detachment
  • Known human immunodeficiency virus infection
  • Employee, or immediate relative of an employee, of the Sponsor, any of its affiliates or partners, or the study center

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks.
Drug: Placebo
Experimental: Cariprazine 1.5 mg
Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks.
Drug: Cariprazine
Other Names:
  • VRAYLAR®
Experimental: Cariprazine 3.0 mg
Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 milligram (mg) capsule, one per day, orally beginning on Day 15 for 4 weeks.
Drug: Cariprazine
Other Names:
  • VRAYLAR®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6
Time Frame: Baseline (Week 0) to Week 6
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each of the 10 items was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement.
Baseline (Week 0) to Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6
Time Frame: Baseline (Week 0) to Week 6
The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of other participants the physician has observed. The participant was rated on a scale from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A negative change from Baseline indicates improvement.
Baseline (Week 0) to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Forest Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clincial Director, Forest Research Institute, Inc., an affiliate of Allergan, plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 19, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RGH-MD-54
  • 2016-000757-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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