Cariprazine Relative to Placebo in the Prevention of Relapse of Symptoms in Patients With Schizophrenia
This study is currently recruiting participants.
Verified December 2012 by Forest Laboratories
Sponsor:
Forest Laboratories
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01412060
First received: August 4, 2011
Last updated: December 6, 2012
Last verified: December 2012
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Purpose
The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in patients with schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Cariprazine Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double-Blind, Placebo-controlled, Parallel-group Study of Cariprazine(RGH-188) in the Prevention of Relapse in Patients With Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Forest Laboratories:
Primary Outcome Measures:
- Time from baseline to the first symptom relapse during the Double-Blind phase [ Time Frame: At 17 Weeks and Bi-Weekly thereafter until week 92 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 900 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo
|
Drug: Placebo
Dose-matched placebo, once daily oral administration
|
|
Experimental: 2
Cariprazine, 3- 9mg/day (dosage depends on tolerability)
|
Drug: Cariprazine
Patients who meet eligibility criteria will be administered a once daily oral dose of 3.0 to 9.0 mg cariprazine during the open-label phase and then randomized when they will receive cariprazine or placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 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 DSM-IV-TR criteria for schizophrenia as confirmed by the
- Patients with normal physical examination, laboratory, vital signs,and/ or ECG
- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
- PANSS total score greater than or equal to 70 and less than or equal to 120 at Visit 1 and Visit 2
- Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female patients of childbearing potential only)
- Body mass index between 18 and 40kg/m2, inclusive
Exclusion Criteria:
- Patients currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorders
- Patients in their first episode of Psychosis
- Treatment-resistant schizophrenia over the last 2 years
- Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication
- At imminent risk of injuring self or others or causing significant damage to property
- Suicide risk
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412060
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Contacts
| Contact: Sandra Beaird, PhD | 1-800-678-1605 ext 66297 | info@forestpharm.com |
Hide Study LocationsLocations
| United States, Arkansas | |
| Forest Investigative Site 011 | Recruiting |
| Little Rock, Arkansas, United States, 72211 | |
| Forest Investigative Site 016 | Withdrawn |
| Springdale, Arkansas, United States, 72764 | |
| United States, California | |
| Forest Investigative Site 018 | Recruiting |
| Cerritos, California, United States, 92626 | |
| Forest Investigative Site 007 | Recruiting |
| Costa Mesa, California, United States, 92626 | |
| Forest Investigative Site 008 | Recruiting |
| Long Beach, California, United States, 90813 | |
| Forest Investigative Site 002 | Recruiting |
| Oceanside, California, United States, 92056 | |
| Forest Investigative Site 001 | Active, not recruiting |
| Paramount, California, United States, 90723 | |
| Forest Investigative Site 020 | Recruiting |
| San Diego, California, United States, 92123 | |
| Forest Investigative Site 019 | Recruiting |
| Santa Ana, California, United States, 92701 | |
| United States, District of Columbia | |
| Forest Investigative Site 005 | Recruiting |
| Washington, District of Columbia, United States, 20016 | |
| United States, Florida | |
| Forest Investigative Site 024 | Recruiting |
| Leesburg, Florida, United States, 34748 | |
| United States, Georgia | |
| Forest Investigative Site 017 | Recruiting |
| Atlanta, Georgia, United States, 30328 | |
| United States, Illinois | |
| Forest Investigative Site 021 | Recruiting |
| Chicago, Illinois, United States, 60640 | |
| United States, Maryland | |
| Forest Investigative Site 023 | Recruiting |
| Baltimore, Maryland, United States, 21202 | |
| Forest Investigative Site 010 | Recruiting |
| Rockville, Maryland, United States, 20850 | |
| United States, Mississippi | |
| Forest Investigative Site 003 | Recruiting |
| Flowood, Mississippi, United States, 39232 | |
| United States, Missouri | |
| Forest Investigative Site 006 | Recruiting |
| Creve Coeur, Missouri, United States, 63141 | |
| Forest Investigative Site 014 | Recruiting |
| St. Louis, Missouri, United States, 63118 | |
| United States, Ohio | |
| Forest Investigative Site 022 | Recruiting |
| Dayton, Ohio, United States, 45471 | |
| United States, Texas | |
| Forest Investigative Site 015 | Recruiting |
| Austin, Texas, United States, 78731 | |
| Forest Investigative Site 013 | Recruiting |
| Houston, Texas, United States, 77008 | |
| Forest Investigative Site 009 | Recruiting |
| Houston, Texas, United States, 77021 | |
| India | |
| Forest Investigative Site 305 | Recruiting |
| Vijaywada, Andhra Pradesh, India, 520002 | |
| Forest Investigative Site 303 | Recruiting |
| Ahmedabad, Gujarat, India, 380006 | |
| Forest Investigative Site 308 | Recruiting |
| Ahmedabad, Gujarat, India, 380006 | |
| Forest Investigative Site 310 | Recruiting |
| Ahmedabad, Gujarat, India, 380015 | |
| Forest Investigative Site 313 | Recruiting |
| Mangalore, Karnataka, India, 575018 | |
| Forest Investigative Site 315 | Recruiting |
| Mangalore, Karnataka, India, 575001 | |
| Forest Investigative Site 314 | Recruiting |
| Manipal, Karnataka, India, 576104 | |
| Forest Investigative Site 301 | Recruiting |
| Aurangabad, Maharashtra, India, 431005 | |
| Forest Investigative Site 306 | Recruiting |
| Kalyan, Maharashtra, India, 421301 | |
| Forest Investigative Site 311 | Recruiting |
| Nashik, Maharashtra, India, 422101 | |
| Forest Investigative Site 302 | Recruiting |
| Jaipur, Rajasthan, India, 303706 | |
| Forest Investigative Site 317 | Recruiting |
| Jaipur, Rajasthan, India, 302021 | |
| Forest Investigative Site 312 | Recruiting |
| Madurai, Tamilnadu, India, 625020 | |
| Forest Investigative Site 309 | Recruiting |
| Kanpur, Uttar Pradesh, India, 208005 | |
| Forest Investigative Site 304 | Recruiting |
| Lucknow, Uttar Pradesh, India, 226003 | |
| Forest Investigative Site 307 | Recruiting |
| Varanasi, Uttar Pradesh, India, 201005 | |
| Romania | |
| Forest Investigative Site 403 | Recruiting |
| Bucuresti, Romania, 041914 | |
| Forest Investigative Site 406 | Recruiting |
| Bucuresti, Romania, 041914 | |
| Forest Investigative Site 408 | Recruiting |
| Bucuresti, Romania, 041914 | |
| Forest Investigative Site 402 | Recruiting |
| Constanta, Romania, 900002 | |
| Forest Investigative Site 401 | Recruiting |
| Iasi, Romania, 700282 | |
| Forest Investigative Site 409 | Recruiting |
| Iasi, Romania, 700282 | |
| Forest Investigative Site 404 | Recruiting |
| Targoviste, Romania, 130086 | |
| Slovakia | |
| Forest Investigative Site 504 | Recruiting |
| Liptovsky Mikulas, Slovakia, 3123 | |
| Forest Investigative Site 503 | Recruiting |
| Roznava, Slovakia, 4801 | |
| Ukraine | |
| Forest Investigative Site 609 | Recruiting |
| Kerch, AR Crimea, Ukraine, 98310 | |
| Forest Investigative Site 607 | Recruiting |
| Kherson, Vil. Stepanizka, Ukraine, 73488 | |
| Forest Investigative Site 610 | Recruiting |
| Dnipropetrovsk, Ukraine, 49115 | |
| Forest Investigative Site 606 | Recruiting |
| Kharkiv, Ukraine, 61068 | |
| Forest Investigative Site 604 | Recruiting |
| Kharkiv, Ukraine, 61103 | |
| Forest Investigative Site 605 | Recruiting |
| Kharkiv, Ukraine, 61068 | |
| Forest Investigative Site 601 | Recruiting |
| Kyiv, Ukraine, 4080 | |
| Forest Investigative Site 603 | Recruiting |
| Lviv, Ukraine, 79021 | |
| Forest Investigative Site 611 | Recruiting |
| Simferopol, Ukraine, 95006 | |
| Forest Investigative Site 608 | Recruiting |
| Vinnitsa, Ukraine, 21005 | |
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
| Study Director: | Suresh Durgam, MD | Forest Laboratories |
More Information
Additional Information:
No publications provided
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT01412060 History of Changes |
| Other Study ID Numbers: | RGH-MD-06, 2011-002048-29 |
| Study First Received: | August 4, 2011 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Food and Drug Administration India: Drugs Controller General of India India: Institutional Review Board Romania: Ethics Committee Romania: National Agency for Medicines and Medical Devices Ukraine: Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health |
Keywords provided by Forest Laboratories:
|
Schizophrenia Schizophrenic Disorder |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013