Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
- Registration Number
- NCT01396447
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 584
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received placebo orally once a day for 8 weeks. Cariprazine 1.5 mg Cariprazine 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. Cariprazine 0.75 mg Cariprazine 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. Cariprazine 3.0 mg Cariprazine 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6 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
Name Time Method Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6 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.
Trial Locations
- Locations (88)
Forest Investigative Site 007
🇺🇸Dallas, Texas, United States
Forest Investigative Site 038
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 005
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 029
🇺🇸Chicago, Illinois, United States
Forest Investigative Site 009
🇺🇸Allentown, Pennsylvania, United States
Forest Investigative Site 012
🇺🇸Jacksonville, Florida, United States
Forest Investigative Site 019
🇺🇸Memphis, Tennessee, United States
Forest Investigative Site 010
🇺🇸Media, Pennsylvania, United States
Forest Investigative Site 028
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 603
🇷🇺Nizhniy Novgorod, Russian Federation
Forest Investigative Site 102
🇨🇦Kelowna, British Columbia, Canada
Forest Investigative Site 103
🇨🇦Penticton, British Columbia, Canada
Forest Investigative Site 015
🇺🇸Oceanside, California, United States
Forest Investigative Site 302
🇧🇬Pleven, Bulgaria
Forest Investigative Site 804
🇨🇴Barranquilla, Colombia
Forest Investigative Site 601
🇷🇺Arkhangelsk, Russian Federation
Forest Investigative Site 033
🇺🇸Lincoln, Rhode Island, United States
Forest Investigative Site 312
🇧🇬Tserova Koria, Bulgaria
Forest Investigative Site 020
🇺🇸San Antonio, Texas, United States
Forest Investigative Site 307
🇧🇬Kazanlak, Bulgaria
Forest Investigative Site 301
🇧🇬Plovdiv, Bulgaria
Forest Investigative Site 309
🇧🇬Pazardzhik, Bulgaria
Forest Investigative Site 313
🇧🇬Novi Iskar, Bulgaria
Forest Investigative Site 043
🇺🇸Bellevue, Washington, United States
Forest Investigative Site 617
🇷🇺Samara, Russian Federation
Forest Investigative Site 311
🇧🇬Kardzhali, Bulgaria
Forest Investigative Site 032
🇺🇸Seattle, Washington, United States
Forest Investigative Site 308
🇧🇬Tsarev Brod, Bulgaria
Forest Investigative Site 310
🇧🇬Lovech, Bulgaria
Forest Investigative Site 618
🇷🇺Tver, Russian Federation
Forest Investigative Site 708
🇺🇦Kyiv, Ukraine
Forest Investigative Site 702
🇺🇦Kharkiv, Ukraine
Forest Investigative Site 101
🇨🇦Chatham, Ontario, Canada
Forest Investigative Site 021
🇺🇸Birmingham, Alabama, United States
Forest Investigative Site 611
🇷🇺Moscow, Russian Federation
Forest Investigative Site 604
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 606
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 619
🇷🇺Moscow, Russian Federation
Forest Investigative Site 612
🇷🇺Saint-Petersburg, Russian Federation
Forest Investigative Site 616
🇷🇺Saratov, Russian Federation
Forest Investigative Site 602
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 613
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 608
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 609
🇷🇺Tomsk, Russian Federation
Forest Investigative Site 610
🇷🇺Voronezh, Russian Federation
Forest Investigative Site 305
🇧🇬Sofia, Bulgaria
Forest Investigative Site 306
🇧🇬Sofia, Bulgaria
Forest Investigative Site 017
🇺🇸Springdale, Arkansas, United States
Forest Investigative Site 018
🇺🇸Cerritos, California, United States
Forest Investigative Site 013
🇺🇸Winter Park, Florida, United States
Forest Investigative Site 035
🇺🇸Orlando, Florida, United States
Forest Investigative Site 011
🇺🇸Temecula, California, United States
Forest Investigative Site 024
🇺🇸Indianapolis, Indiana, United States
Forest Investigative Site 031
🇺🇸Prairie Village, Kansas, United States
Forest Investigative Site 041
🇺🇸Lake Charles, Louisiana, United States
Forest Investigative Site 040
🇺🇸Shreveport, Louisiana, United States
Forest Investigative Site 037
🇺🇸Las Vegas, Nevada, United States
Forest Investigative Site 039
🇺🇸Flowood, Mississippi, United States
Forest Investigative Site 808
🇨🇴Bogotá, Colombia
Forest Investigative Site 023
🇺🇸Cherry Hill, New Jersey, United States
Forest Investigative Site 014
🇺🇸Marlton, New Jersey, United States
Forest Investigative Site 026
🇺🇸Creve Coeur, Missouri, United States
Forest Investigative Site 006
🇺🇸Albuquerque, New Mexico, United States
Forest Investigative Site 036
🇺🇸Canton, Ohio, United States
Forest Investigative Site 003
🇺🇸Brooklyn, New York, United States
Forest Investigative Site 008
🇺🇸Dayton, Ohio, United States
Forest Investigative Site 025
🇺🇸New York, New York, United States
Forest Investigative Site 042
🇺🇸Salem, Oregon, United States
Forest Investigative Site 027
🇺🇸Houston, Texas, United States
Forest Investigative Site 016
🇺🇸Houston, Texas, United States
Forest Investigative Site 803
🇨🇴Bogota, Colombia
Forest Investigative Site 805
🇨🇴Bogotá, Colombia
Forest Investigative Site 605
🇷🇺Moscow, Russian Federation
Forest Investigative Site 607
🇷🇺Moscow, Russian Federation
Forest Investigative Site 615
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 712
🇺🇦Ivano-Frankivsk, Ukraine
Forest Investigative Site 701
🇺🇦Kyiv, Ukraine
Forest Investigative Site 806
🇨🇴Barranquilla, Colombia
Forest Investigative Site 714
🇺🇦Donetsk, Ukraine
Forest Investigative Site 704
🇺🇦Kharkiv, Ukraine
Forest Investigative Site 703
🇺🇦Kharkiv, Ukraine
Forest Investigative Site 710
🇺🇦Odesa, Ukraine
Forest Investigative Site 807
🇨🇴Pereira, Colombia
Forest Investigative Site 707
🇺🇦Kerch, AR Crimea, Ukraine
Forest Investigative Site 709
🇺🇦Kherson, Vil. Stepanivka, Ukraine
Forest Investigative Site 706
🇺🇦Simferopol, Ukraine
Forest Investigative Site 705
🇺🇦Vinnytsia, Ukraine
Forest Investigative Site 030
🇺🇸Beverly Hills, California, United States