Long-term Study of Cariprazine in Patients With Schizophrenia
This study has been completed.
Sponsor:
Forest Laboratories
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01104792
First received: April 12, 2010
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
The objective of this study is to evaluate the long-term safety, tolerability and pharmacokinetics of cariprazine in patients with schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Cariprazine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of the Long-Term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Safety: adverse event recording, clinical laboratory parameters, vital signs, electrocardiograms and other [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics: Plasma concentrations of cariprazine and its metabolites [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 588 |
| Study Start Date: | April 2010 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Cariprazine flexible dose, oral administration once daily for 48 weeks
|
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.
Other Name: RGH-188
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients and corresponding caregivers who have provided informed consents 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 schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
- Patients with normal physical examination, laboratory, vital signs and electrocardiogram (ECG)
Exclusion Criteria:
- Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104792
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| United States, Arkansas | |
| Forest Investigative Site 072 | |
| Little Rock, Arkansas, United States, 72201 | |
| Forest Investigative Site 086 | |
| Little Rock, Arkansas, United States, 72211 | |
| Forest Investigative Site 021 | |
| Little Rock, Arkansas, United States, 72211 | |
| Forest Investigative Site 014 | |
| Springdale, Arkansas, United States, 72764 | |
| United States, California | |
| Forest Investigative Site 080 | |
| Carson, California, United States, 90746 | |
| Forest Investigative Site 079 | |
| Cerritos, California, United States, 90703 | |
| Forest Investigative Site 048 | |
| Costa Mesa, California, United States, 92626 | |
| Forest Investigative Site 070 | |
| Costa Mesa, California, United States, 92626 | |
| Forest Investigative Site 022 | |
| Garden Grove, California, United States, 92845 | |
| Forest Investigative Site 083 | |
| Garden Grove, California, United States, 92845 | |
| Forest Investigative Site 050 | |
| Long Beach, California, United States, 90813 | |
| Forest Investigative Site 006 | |
| Oceanside, California, United States, 92056 | |
| Forest Investigative Site 003 | |
| Riverside, California, United States, 92506 | |
| Forest Investigative Site 016 | |
| San Diego, California, United States, 92123 | |
| Forest Investigative Site 073 | |
| Santa Ana, California, United States, 92701 | |
| United States, Connecticut | |
| Forest Investigative Site 071 | |
| New Britain, Connecticut, United States, 06050 | |
| United States, Florida | |
| Forest Investigative Site 002 | |
| Bradenton, Florida, United States, 34208 | |
| Forest Investigative Site 041 | |
| Kissimmee, Florida, United States, 34741 | |
| Forest Investigative Site 082 | |
| North Miami, Florida, United States, 33161 | |
| United States, Georgia | |
| Forest Investigative Site 087 | |
| Atlanta, Georgia, United States, 30308 | |
| Forest Investigative Site 055 | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Hawaii | |
| Forest Investigative Site 012 | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Forest Investigative Site 018 | |
| Chicago, Illinois, United States, 60640 | |
| Forest Investigative Site 008 | |
| Hoffman Estates, Illinois, United States, 60169 | |
| United States, Maryland | |
| Forest Investigative Site 044 | |
| Rockville, Maryland, United States, 20850 | |
| United States, Mississippi | |
| Forest Investigative Site 007 | |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| Forest Investigative Site 017 | |
| Creve Coeur, Missouri, United States, 63141 | |
| Forest Investigative Site 076 | |
| St. Charles, Missouri, United States, 63301 | |
| Forest Investigative Site 045 | |
| St. Louis, Missouri, United States, 63118 | |
| United States, Nevada | |
| Forest Investigative Site 052 | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Jersey | |
| Forest Investigative Site 004 | |
| Willingboro, New Jersey, United States, 08046 | |
| United States, New York | |
| Forest Investigative Site 040 | |
| Cedarhurst, New York, United States, 11516 | |
| United States, Ohio | |
| Forest Investigative Site 019 | |
| Willoughby, Ohio, United States, 44094 | |
| United States, Pennsylvania | |
| Forest Investigative Site 077 | |
| Philadelphia, Pennsylvania, United States, 19131 | |
| Forest Investigative Site 047 | |
| Philadelphia, Pennsylvania, United States, 19139 | |
| United States, Texas | |
| Forest Investigative Site 074 | |
| Austin, Texas, United States, 78756 | |
| Forest Investigative Site 084 | |
| DeSoto, Texas, United States, 75115 | |
| Forest Investigative Site 043 | |
| Irving, Texas, United States, 75062 | |
| United States, Washington | |
| Forest Investigative Site 078 | |
| Bellevue, Washington, United States, 98007 | |
| Colombia | |
| Forest Investigative Site 601 | |
| Bello, Antioquia, Colombia, 051053 | |
| Forest Investigative Site 604 | |
| Pereira, Risaralda, Colombia, 660003 | |
| Forest Investigative Site 605 | |
| Bogota, Colombia, 111166 | |
| Forest Investigative Site 602 | |
| Bogota, Colombia, 110121 | |
| India | |
| Forest Investigative Site 519 | |
| Ahmedabad, India, 380006 | |
| Forest Investigative Site 501 | |
| Ahmedabad, India, 380013 | |
| Forest Investigative Site 503 | |
| Ahmedabad, India, 380006 | |
| Forest Investigative Site 500 | |
| Aurangabad, India, 431005 | |
| Forest Investigative Site 507 | |
| Kanpur, India, 208005 | |
| Forest Investigative Site 518 | |
| Lucknow, India, 226006 | |
| Forest Investigative Site 517 | |
| Mangalore, India, 575001 | |
| Forest Investigative Site 515 | |
| Mangalore, India, 575018 | |
| Forest Investigative Site 510 | |
| Mumbai, India, 400026 | |
| Forest Investigative Site 513 | |
| Nashik, India, 422101 | |
| Forest Investigative Site 509 | |
| Rajkot, India, 360002 | |
| Forest Investigative Site 506 | |
| Varanasi, India, 201010 | |
| Forest Investigative Site 505 | |
| Vijaywada, India, 520002 | |
| Romania | |
| Forest Investigative Site 306 | |
| Bucuresti, Romania, 41914 | |
| Forest Investigative Site 301 | |
| Cluj-Napoca, Romania, 400012 | |
| Forest Investigative Site 300 | |
| Craiova, Romania, 200620 | |
| Forest Investigative Site 311 | |
| Craiova, Romania, 200745 | |
| Forest Investigative Site 303 | |
| Targoviste, Romania, 130086 | |
| Forest Investigative Site 304 | |
| Targu Mures, Romania, 540142 | |
| Russian Federation | |
| Forest Investigative Site 102 | |
| Arkhangelsk, Russian Federation, 163530 | |
| Forest Investigative Site 103 | |
| Chelyabinsk, Russian Federation, 454087 | |
| Forest Investigative Site 104 | |
| Chita, Russian Federation, 672090 | |
| Forest Investigative Site 110 | |
| Saratov, Russian Federation, 410028 | |
| Forest Investigative Site 108 | |
| Saratov, Russian Federation, 410060 | |
| Forest Investigative Site 107 | |
| St. Petersburg, Russian Federation, 193167 | |
| Forest Investigative Site 106 | |
| St. Petersburg, Russian Federation, 192019 | |
| Forest Investigative Site 105 | |
| St. Petersburg, Russian Federation, 192019 | |
| Forest Investigative Site 109 | |
| St. Petersburg, Russian Federation, 197341 | |
| Forest Investigative Site 112 | |
| St. Petersburg, Russian Federation, 190121 | |
| Forest Investigative Site 113 | |
| St. Petersburg, Russian Federation, 192019 | |
| Forest Investigative Site 100 | |
| Tomsk, Russian Federation, 634014 | |
| Ukraine | |
| Forest Investigative Site 211 | |
| Glevakha, Kyiv region, Ukraine, 08631 | |
| Forest Investigative Site 206 | |
| Kherson, Stepanivka, Ukraine, 73488 | |
| Forest Investigative Site 208 | |
| Dnipropetrovsk, Ukraine, 49005 | |
| Forest Investigative Site 205 | |
| Dnipropetrovsk, Ukraine, 49027 | |
| Forest Investigative Site 200 | |
| Donetsk, Ukraine, 83008 | |
| Forest Investigative Site 204 | |
| Kharkiv, Ukraine, 61068 | |
| Forest Investigative Site 203 | |
| Kharkov, Ukraine, 61068 | |
| Forest Investigative Site 201 | |
| Kyiv, Ukraine, 04080 | |
| Forest Investigative Site 202 | |
| Lviv, Ukraine, 79021 | |
| Forest Investigative Site 209 | |
| Poltava, Ukraine, 36006 | |
| Forest Investigative Site 210 | |
| Simferopol, Ukraine, 95006 | |
| Forest Investigative Site 207 | |
| Vinnytsya, Ukraine, 21005 | |
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
| Study Director: | Raffaele Migliore, MA | Forest Laboratories |
More Information
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01104792 History of Changes |
| Other Study ID Numbers: | RGH-MD-11 |
| Study First Received: | April 12, 2010 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration India: Drugs Controller General of India Colombia: National Institutes of Health South Africa: Department of Health Ukraine: Ministry of Health Russia: Ministry of Health of the Russian Federation Romania: National Medicines Agency Lithuania: State Medicine Control Agency - Ministry of Health |
Keywords provided by Forest Laboratories:
|
Schizophrenia Acute Schizophrenia Psychotropic Drugs Antipsychotic Agents |
Mental Disorders Dopamine Agents Central Nervous System Agents |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Central Nervous System Agents Antipsychotic Agents Therapeutic Uses |
Pharmacologic Actions Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 18, 2013