Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

March 29, 2018 updated by: Forest Laboratories

A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression

The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

584

Phase

  • Phase 2

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
      • Kardzhali, Bulgaria, 6600
        • Forest Investigative Site 311
      • Kazanlak, Bulgaria, 6100
        • Forest Investigative Site 307
      • Lovech, Bulgaria, 5500
        • Forest Investigative Site 310
      • Novi Iskar, Bulgaria, 1282
        • Forest Investigative Site 313
      • Pazardzhik, Bulgaria, 4400
        • Forest Investigative Site 309
      • Pleven, Bulgaria, 5800
        • Forest Investigative Site 302
      • Plovdiv, Bulgaria, 4002
        • Forest Investigative Site 301
      • Sofia, Bulgaria, 1431
        • Forest Investigative Site 305
      • Sofia, Bulgaria, 1431
        • Forest Investigative Site 306
      • Tsarev Brod, Bulgaria, 9747
        • Forest Investigative Site 308
      • Tserova Koria, Bulgaria, 5047
        • Forest Investigative Site 312
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Forest Investigative Site 102
      • Penticton, British Columbia, Canada, V2A 4M4
        • Forest Investigative Site 103
    • Ontario
      • Chatham, Ontario, Canada, N7L 5L9
        • Forest Investigative Site 101
  • Colombia
      • Barranquilla, Colombia
        • Forest Investigative Site 804
      • Barranquilla, Colombia
        • Forest Investigative Site 806
      • Bogota, Colombia
        • Forest Investigative Site 803
      • Bogotá, Colombia
        • Forest Investigative Site 805
      • Bogotá, Colombia
        • Forest Investigative Site 808
      • Pereira, Colombia
        • Forest Investigative Site 807
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163530
        • Forest Investigative Site 601
      • Moscow, Russian Federation, 107076
        • Forest Investigative Site 605
      • Moscow, Russian Federation, 115522
        • Forest Investigative Site 607
      • Moscow, Russian Federation, 117152
        • Forest Investigative Site 611
      • Moscow, Russian Federation, 127083
        • Forest Investigative Site 619
      • Nizhniy Novgorod, Russian Federation, 603152
        • Forest Investigative Site 603
      • Saint-Petersburg, Russian Federation, 199034
        • Forest Investigative Site 612
      • Samara, Russian Federation, 443016
        • Forest Investigative Site 617
      • Saratov, Russian Federation, 410028
        • Forest Investigative Site 616
      • St. Petersburg, Russian Federation, 190005
        • Forest Investigative Site 604
      • St. Petersburg, Russian Federation, 190121
        • Forest Investigative Site 606
      • St. Petersburg, Russian Federation, 191119
        • Forest Investigative Site 602
      • St. Petersburg, Russian Federation, 191119
        • Forest Investigative Site 613
      • St. Petersburg, Russian Federation, 192019
        • Forest Investigative Site 608
      • St. Petersburg, Russian Federation, 192019
        • Forest Investigative Site 615
      • Tomsk, Russian Federation, 634014
        • Forest Investigative Site 609
      • Tver, Russian Federation, 170005
        • Forest Investigative Site 618
      • Voronezh, Russian Federation, 394052
        • Forest Investigative Site 610
  • Ukraine
      • Donetsk, Ukraine, 83008
        • Forest Investigative Site 714
      • Ivano-Frankivsk, Ukraine, 76014
        • Forest Investigative Site 712
      • Kharkiv, Ukraine, 61068
        • Forest Investigative Site 703
      • Kharkiv, Ukraine, 61068
        • Forest Investigative Site 704
      • Kharkiv, Ukraine, 61103
        • Forest Investigative Site 702
      • Kyiv, Ukraine, 04080
        • Forest Investigative Site 701
      • Kyiv, Ukraine, 02660
        • Forest Investigative Site 708
      • Odesa, Ukraine, 65014
        • Forest Investigative Site 710
      • Simferopol, Ukraine, 95006
        • Forest Investigative Site 706
      • Vinnytsia, Ukraine, 21005
        • Forest Investigative Site 705
    • AR Crimea
      • Kerch, AR Crimea, Ukraine, 98310
        • Forest Investigative Site 707
    • Vil. Stepanivka
      • Kherson, Vil. Stepanivka, Ukraine, 73488
        • Forest Investigative Site 709
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Forest Investigative Site 021
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Forest Investigative Site 017
    • California
      • Beverly Hills, California, United States, 90210
        • Forest Investigative Site 030
      • Cerritos, California, United States, 90703
        • Forest Investigative Site 018
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 028
      • Oceanside, California, United States, 92056
        • Forest Investigative Site 015
      • Temecula, California, United States, 92591
        • Forest Investigative Site 011
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Forest Investigative Site 012
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site 035
      • Winter Park, Florida, United States, 32789
        • Forest Investigative Site 013
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Forest Investigative Site 038
      • Atlanta, Georgia, United States, 30328
        • Forest Investigative Site 005
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Forest Investigative Site 029
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Forest Investigative Site 024
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Forest Investigative Site 031
    • Louisiana
      • Lake Charles, Louisiana, United States, 70629
        • Forest Investigative Site 041
      • Shreveport, Louisiana, United States, 71104
        • Forest Investigative Site 040
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Forest Investigative Site 039
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Forest Investigative Site 026
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Forest Investigative Site 037
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Forest Investigative Site 023
      • Marlton, New Jersey, United States, 08053
        • Forest Investigative Site 014
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Forest Investigative Site 006
    • New York
      • Brooklyn, New York, United States, 11214
        • Forest Investigative Site 003
      • New York, New York, United States, 10021
        • Forest Investigative Site 025
    • Ohio
      • Canton, Ohio, United States, 44718
        • Forest Investigative Site 036
      • Dayton, Ohio, United States, 45417
        • Forest Investigative Site 008
    • Oregon
      • Salem, Oregon, United States, 97301
        • Forest Investigative Site 042
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Forest Investigative Site 009
      • Media, Pennsylvania, United States, 19063
        • Forest Investigative Site 010
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Forest Investigative Site 033
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Forest Investigative Site 019
    • Texas
      • Dallas, Texas, United States, 75231
        • Forest Investigative Site 007
      • Houston, Texas, United States, 77008
        • Forest Investigative Site 016
      • Houston, Texas, United States, 77054
        • Forest Investigative Site 027
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 020
    • Washington
      • Bellevue, Washington, United States, 98007
        • Forest Investigative Site 043
      • Seattle, Washington, United States, 98104
        • Forest Investigative Site 032

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants who have provided informed consent prior to any study specific procedures.
  • Participants 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 (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
  • Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
  • Verified previous manic or mixed episode.
  • Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
  • Participants with a HAMD-17 item 1 score ≥ 2.
  • Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion Criteria:

  • Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
  • Women who are pregnant or breast feeding
  • Participants with Young Mania Rating Scale (YMRS) total score > 10
  • Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.

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
Intervention / Treatment
Placebo Comparator: Placebo
Participants received placebo orally once a day for 8 weeks.
Drug: Placebo
Placebo was supplied in capsules.
Experimental: Cariprazine 0.75 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
Drug: Cariprazine
Cariprazine was supplied in capsules.
Experimental: Cariprazine 1.5 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
Drug: Cariprazine
Cariprazine was supplied in capsules.
Experimental: Cariprazine 3.0 mg
Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Drug: Cariprazine
Cariprazine was supplied in capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6
Time Frame: Baseline to Week 6
The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.
Baseline to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6
Time Frame: Baseline to Week 6
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.
Baseline to Week 6

Collaborators and Investigators

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

Sponsor

Forest Laboratories

Collaborators

Gedeon Richter Ltd.

Investigators

  • Study Director: Willie Earley, MD, Allergan

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)

July 26, 2011

Primary Completion (Actual)

January 10, 2014

Study Completion (Actual)

January 10, 2014

Study Registration Dates

First Submitted

July 15, 2011

First Submitted That Met QC Criteria

July 15, 2011

First Posted (Estimate)

July 18, 2011

Study Record Updates

Last Update Posted (Actual)

May 1, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGH-MD-56
  • 2011-002334-39 (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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