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

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ClinicalTrials.gov Identifier: NCT01396447
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression, Bipolar Drug: Placebo Drug: Cariprazine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression
Actual Study Start Date : July 26, 2011
Actual Primary Completion Date : January 10, 2014
Actual Study Completion Date : January 10, 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396447


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01396447     History of Changes
Other Study ID Numbers: RGH-MD-56
2011-002334-39 ( EudraCT Number )
First Posted: July 18, 2011    Key Record Dates
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018
Last Verified: March 2018

Keywords provided by Forest Laboratories:
Bipolar I disorder
Bipolar depression
Depression
Bipolar disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders