Safety, Tolerability, and Efficacy of Cariprazine for Patients With Bipolar Depression
This study is currently recruiting participants.
Verified April 2013 by Forest Laboratories
Sponsor:
Forest Laboratories
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01396447
First received: July 15, 2011
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of patients with bipolar depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression, Bipolar |
Drug: Placebo Drug: Cariprazine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 6 to Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Week 6 to Week 8 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo
|
Drug: Placebo
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo
|
|
Experimental: 2
Cariprazine, 0.75 mg/day
|
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine
|
|
Experimental: 3
Cariprazine, 1.5 mg/day
|
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine
|
|
Experimental: 4
Cariprazine, 3.0 mg/day
|
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who have provided informed consent prior to any study specific procedures
- Patients 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 for DSM-IV-TR (SCID) bipolar I depression without psychotic features
- Patients with normal physical examination, laboratory, vital signs,and/ or ECG
- Verified previous manic or mixed episode
- Patients with a total Hamilton Rating Scale for Depression (HAMD)-17 score greater than or equal to 20
- Patients with a HAMD-17 item 1 score greater than or equal to 2
- Patients with a (Clinical Global Impression of Severity) CGI-S score of greater than or equal to 4
Exclusion Criteria:
- Patients 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 six months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396447
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Contacts
| Contact: Sandra Beaird, PhD | 1-800-678-1605 ext 66297 | info@forestpharm.com |
Hide Study LocationsLocations
| United States, Alabama | |
| Forest Investigative Site 021 | Recruiting |
| Birmingham, Alabama, United States, 35216 | |
| United States, Arkansas | |
| Forest Investigative Site 017 | Terminated |
| Springdale, Arkansas, United States, 72764 | |
| United States, California | |
| Forest Investigative Site 030 | Recruiting |
| Beverly Hills, California, United States, 90210 | |
| Forest Investigative Site 018 | Recruiting |
| Cerritos, California, United States, 90703 | |
| Forest Investigative Site 028 | Recruiting |
| Costa Mesa, California, United States, 92626 | |
| Forest Investigative Site 015 | Recruiting |
| Oceanside, California, United States, 92056 | |
| Forest Investigative Site 022 | Active, not recruiting |
| San Diego, California, United States, 92123 | |
| Forest Investigative Site 011 | Recruiting |
| Temecula, California, United States, 92591 | |
| United States, Colorado | |
| Forest Investigative Site 002 | Withdrawn |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Forest Investigative Site 012 | Recruiting |
| Jacksonville, Florida, United States, 32216 | |
| Forest Investigative Site 035 | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Forest Investigative Site 013 | Active, not recruiting |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| Forest Investigative Site 005 | Recruiting |
| Atlanta, Georgia, United States, 30328 | |
| Forest Investigative Site 038 | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Forest Investigative Site 029 | Completed |
| Chicago, Illinois, United States, 60640 | |
| United States, Indiana | |
| Forest Investigative Site 024 | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kansas | |
| Forest Investigative Site 031 | Recruiting |
| Prairie Village, Kansas, United States, 66208 | |
| United States, Louisiana | |
| Forest Investigative Site 041 | Recruiting |
| Lake Charles, Louisiana, United States, 70629 | |
| Forest Investigative Site 040 | Recruiting |
| Shreveport, Louisiana, United States, 71104 | |
| United States, Maryland | |
| Forest Investigative Site 001 | Completed |
| Towson, Maryland, United States, 21204 | |
| United States, Mississippi | |
| Forest Investigative Site 039 | Recruiting |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| Forest Investigative Site 026 | Recruiting |
| Creve Coeur, Missouri, United States, 63141 | |
| United States, Nevada | |
| Forest Investigative Site 037 | Recruiting |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| Forest Investigative Site 023 | Recruiting |
| Cherry Hill, New Jersey, United States, 08002 | |
| Forest Investigative Site 014 | Recruiting |
| Willingboro, New Jersey, United States, 08046 | |
| United States, New Mexico | |
| Forest Investigative Site 006 | Recruiting |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Forest Investigative Site 003 | Recruiting |
| Brooklyn, New York, United States, 11214 | |
| Forest Investigative Site 025 | Recruiting |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Forest Investigative Site 004 | Completed |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Forest Investigative Site 036 | Recruiting |
| Canton, Ohio, United States, 44718 | |
| Forest Investigative Site 008 | Recruiting |
| Dayton, Ohio, United States, 45417 | |
| United States, Oregon | |
| Forest Investigative Site 042 | Recruiting |
| Salem, Oregon, United States, 98007 | |
| United States, Pennsylvania | |
| Forest Investigative Site 009 | Recruiting |
| Allentown, Pennsylvania, United States, 18104 | |
| Forest Investigative Site 010 | Recruiting |
| Media, Pennsylvania, United States, 19063 | |
| United States, Rhode Island | |
| Forest Investigative Site 033 | Terminated |
| Lincoln, Rhode Island, United States, 02865 | |
| United States, Tennessee | |
| Forest Investigative Site 019 | Recruiting |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Forest Investigative Site 007 | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Forest Investigative Site 016 | Recruiting |
| Houston, Texas, United States, 77008 | |
| Forest Investigative Site 027 | Recruiting |
| Houston, Texas, United States, 77054 | |
| Forest Investigative Site 020 | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Forest Investigative Site 034 | Active, not recruiting |
| San Antonio, Texas, United States, 78229 | |
| United States, Washington | |
| Forest Investigative Site 032 | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Argentina | |
| Forest Investigative Site 213 | Not yet recruiting |
| Banfield, Buenos Aires, Argentina, B1828CKR | |
| Forest Investigative Site 203 | Not yet recruiting |
| La Plata, Buenos Aires, Argentina, 1900 | |
| Forest Investigative Site 205 | Not yet recruiting |
| La Plata, Buenos Aires, Argentina, 1900 | |
| Forest Investigative Site 204 | Not yet recruiting |
| Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1058 | |
| Forest Investigative Site 202 | Not yet recruiting |
| Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1181 | |
| Forest Investigative Site 211 | Not yet recruiting |
| Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1117 | |
| Forest Investigative Site 206 | Not yet recruiting |
| Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1405BCH | |
| Forest Investigative Site 207 | Not yet recruiting |
| Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1117 | |
| Forest Investigative Site 209 | Not yet recruiting |
| Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, 1405 | |
| Forest Investigative Site 212 | Not yet recruiting |
| Ciudad de Mendoza, Mendoza, Argentina, M5502AHV | |
| Forest Investigative Site 201 | Not yet recruiting |
| Buenos Aires, Argentina, C1425AHQ | |
| Forest Investigative Site 208 | Not yet recruiting |
| Cordoba, Argentina, X5009BIN | |
| Forest Investigative Site 210 | Not yet recruiting |
| Santiago del Estero, Argentina, 4200 | |
| Bulgaria | |
| Forest Investigative Site 307 | Recruiting |
| Kazanlak, Bulgaria, 6100 | |
| Forest Investigative Site 302 | Recruiting |
| Pleven, Bulgaria, 5800 | |
| Forest Investigative Site 301 | Recruiting |
| Plovdiv, Bulgaria, 4002 | |
| Forest Investigative Site 304 | Not yet recruiting |
| Sofia, Bulgaria, 1606 | |
| Forest Investigative Site 305 | Recruiting |
| Sofia, Bulgaria, 1431 | |
| Forest Investigative Site 306 | Recruiting |
| Sofia, Bulgaria, 1431 | |
| Canada, Alberta | |
| Forest Investigative Site 104 | Completed |
| Medicine Hat, Alberta, Canada, T1B 4E7 | |
| Canada, British Columbia | |
| Forest Investigative Site 102 | Active, not recruiting |
| Kelowna, British Columbia, Canada, V1Y 1Z9 | |
| Forest Investigative Site 103 | Recruiting |
| Penticton, British Columbia, Canada, V2A 4M4 | |
| Forest Investigative Site 105 | Active, not recruiting |
| Victoria, British Columbia, Canada, V8R 4Z3 | |
| Canada, Ontario | |
| Forest Investigative Site 106 | Withdrawn |
| Burlington, Ontario, Canada, L7R 4E2 | |
| Forest Investigative Site 101 | Recruiting |
| Chatham, Ontario, Canada, N7L1B7 | |
| Forest investigative Site 107 | Terminated |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Russian Federation | |
| Forest Investigative Site 601 | Recruiting |
| Arkhangelsk, Russian Federation, 163530 | |
| Forest Investigative Site 605 | Recruiting |
| Moscow, Russian Federation, 107076 | |
| Forest Investigative Site 611 | Recruiting |
| Moscow, Russian Federation, 117152 | |
| Forest Investigative Site 607 | Recruiting |
| Moscow, Russian Federation, 115522 | |
| Forest Investigative Site 603 | Recruiting |
| Nizhniy Novgorod, Russian Federation, 603107 | |
| Forest Investigative Site 612 | Recruiting |
| Saint-Petersburg, Russian Federation, 197183 | |
| Forest Investigative Site 616 | Recruiting |
| Saratov, Russian Federation, 410028 | |
| Forest Investigative Site 608 | Recruiting |
| St. Petersburg, Russian Federation, 192019 | |
| Forest Investigative Site 615 | Recruiting |
| St. Petersburg, Russian Federation, 192019 | |
| Forest Investigative Site 606 | Recruiting |
| St. Petersburg, Russian Federation, 190121 | |
| Forest Investigative Site 613 | Recruiting |
| St. Petersburg, Russian Federation, 197101 | |
| Forest Investigative Site 614 | Not yet recruiting |
| St. Petersburg, Russian Federation, 192019 | |
| Forest Investigative Site 602 | Recruiting |
| St. Petersburg, Russian Federation, 191119 | |
| Forest Investigative Site 604 | Recruiting |
| St. Petersburg, Russian Federation, 190005 | |
| Forest Investigative Site 609 | Recruiting |
| Tomsk, Russian Federation, 634015 | |
| Forest Investigative Site 610 | Recruiting |
| Voronezh, Russian Federation, 394000 | |
| Ukraine | |
| Forest Investigative Site 707 | Recruiting |
| Kerch, AR Crimea, Ukraine, 98310 | |
| Forest Investigative Site 709 | Recruiting |
| Kherson, Vil. Stepanivka, Ukraine, 73488 | |
| Forest Investigative Site 703 | Recruiting |
| Kharkiv, Ukraine, 61068 | |
| Forest Investigative Site 702 | Recruiting |
| Kharkiv, Ukraine, 61103 | |
| Forest Investigative Site 704 | Recruiting |
| Kharkov, Ukraine, 61002 | |
| Forest Investigative Site 701 | Recruiting |
| Kyiv, Ukraine, 4655 | |
| Forest Investigative Site 708 | Recruiting |
| Kyiv, Ukraine, 2660 | |
| Forest Investigative Site 710 | Recruiting |
| Odesa, Ukraine, 65014 | |
| Forest Investigative Site 706 | Recruiting |
| Simferopol, Ukraine, 95006 | |
| Forest Investigative Site 705 | Recruiting |
| Vinnitsa, Ukraine, 21005 | |
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
| Study Director: | Robert Dunn, MD, PhD | Forest Laboratories |
More Information
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01396447 History of Changes |
| Other Study ID Numbers: | RGH-MD-56, 2011-002334-39 |
| Study First Received: | July 15, 2011 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Argentina: Ministry of Health Bulgaria: Ministry of Health Russia: Pharmacological Committee, Ministry of Health Ukraine: Ministry of Health |
Keywords provided by Forest Laboratories:
|
Bipolar I Disorder Bipolar Depression Depression Bipolar Disorder |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013