Cariprazine Relative to Placebo in the Prevention of Relapse of Symptoms in Patients With Schizophrenia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01412060
First received: August 4, 2011
Last updated: July 31, 2014
Last verified: July 2014
  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: November 2014
Estimated Primary Completion Date: September 2014 (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 Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (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
  • Positive and Negative Syndrome Scale (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412060

  Hide Study Locations
Locations
United States, Arkansas
Forest Investigative Site 011
Little Rock, Arkansas, United States, 72211
United States, California
Forest Investigative Site 018
Cerritos, California, United States, 92626
Forest Investigative Site 007
Costa Mesa, California, United States, 92626
Forest Investigative Site 026
Culver City, California, United States, 90230
Forest Investigative Site 008
Long Beach, California, United States, 90813
Forest Investigative Site 002
Oceanside, California, United States, 92056
Forest Investigative Site 001
Paramount, California, United States, 90723
Forest Investigative Site 020
San Diego, California, United States, 92123
Forest Investigative Site 019
Santa Ana, California, United States, 92701
United States, District of Columbia
Forest Investigative Site 005
Washington, District of Columbia, United States, 20016
United States, Florida
Forest Investigative Site 024
Leesburg, Florida, United States, 34748
United States, Georgia
Forest Investigative Site 017
Atlanta, Georgia, United States, 30328
United States, Illinois
Forest Investigative Site 021
Chicago, Illinois, United States, 60640
United States, Maryland
Forest Investigative Site 023
Baltimore, Maryland, United States, 21202
Forest Investigative Site 010
Rockville, Maryland, United States, 20850
United States, Mississippi
Forest Investigative Site 003
Flowood, Mississippi, United States, 39232
United States, Missouri
Forest Investigative Site 006
Creve Coeur, Missouri, United States, 63141
Forest Investigative Site 014
St. Louis, Missouri, United States, 63118
United States, Ohio
Forest Investigative Site 022
Dayton, Ohio, United States, 45471
United States, Texas
Forest Investigative Site 027
Austin, Texas, United States, 78754
Forest Investigative Site 015
Austin, Texas, United States, 78731
Forest Investigative Site 025
Dallas, Texas, United States, 75321
Forest Investigative Site 013
Houston, Texas, United States, 77008
Forest Investigative Site 009
Houston, Texas, United States, 77021
India
Forest Investigative Site 305
Vijaywada, Andhra Pradesh, India, 520002
Forest Investigative Site 303
Ahmedabad, Gujarat, India, 380006
Forest Investigative Site 308
Ahmedabad, Gujarat, India, 380006
Forest Investigative Site 310
Ahmedabad, Gujarat, India, 380015
Forest Investigative Site 313
Mangalore, Karnataka, India, 575018
Forest Investigative Site 315
Mangalore, Karnataka, India, 575001
Forest Investigative Site 314
Manipal, Karnataka, India, 576104
Forest Investigative Site 301
Aurangabad, Maharashtra, India, 431005
Forest Investigative Site 306
Kalyan, Maharashtra, India, 421301
Forest Investigative Site 311
Nashik, Maharashtra, India, 422101
Forest Investigative Site 302
Jaipur, Rajasthan, India, 303706
Forest Investigative Site 317
Jaipur, Rajasthan, India, 302021
Forest Investigative Site 312
Madurai, Tamilnadu, India, 625020
Forest Investigative Site 309
Kanpur, Uttar Pradesh, India, 208005
Forest Investigative Site 304
Lucknow, Uttar Pradesh, India, 226003
Forest Investigative Site 307
Varanasi, Uttar Pradesh, India, 201005
Romania
Forest Investigative Site 403
Bucuresti, Romania, 041914
Forest Investigative Site 410
Bucuresti, Romania, 041914
Forest Investigative Site 405
Bucuresti, Romania, 041914
Forest Investigative Site 408
Bucuresti, Romania, 041914
Forest Investigative Site 406
Bucuresti, Romania, 041914
Forest Investigative Site 412
Campulung, Romania, 115100
Forest Investigative Site 402
Constanta, Romania, 900002
Forest Investigative Site 411
Focsani, Romania, 620165
Forest Investigative Site 409
Iasi, Romania, 700282
Forest Investigative Site 401
Iasi, Romania, 700282
Forest Investigative Site 404
Targoviste, Romania, 130086
Slovakia
Forest Investigative Site 502
Bojnice, Slovakia, 97201
Forest Investigative Site 508
Bratislava, Slovakia, 81369
Forest Investigative Site 507
Bratislava, Slovakia, 82606
Forest Investigative Site 504
Liptovsky Mikulas, Slovakia, 3123
Forest Investigative Site 501
Michalovce, Slovakia, 7101
Forest Investigative Site 505
Rimavska Sobota, Slovakia, 97901
Forest Investigative Site 503
Roznava, Slovakia, 4801
Forest Investigative Site 506
Trnava, Slovakia, 91708
Ukraine
Forest Investigative Site 609
Kerch, AR Crimea, Ukraine, 98310
Forest Investigative Site 607
Kherson, Vil. Stepanizka, Ukraine, 73488
Forest Investigative Site 610
Dnipropetrovsk, Ukraine, 49115
Forest Investigative Site 614
Dnipropetrovsk, Ukraine, 49005
Forest Investigative Site 613
Donetsk, Ukraine, 83037
Forest Investigative Site 616
Ivano-Frankivsk, Ukraine, 76014
Forest Investigative Site 605
Kharkiv, Ukraine, 61068
Forest Investigative Site 604
Kharkiv, Ukraine, 61103
Forest Investigative Site 606
Kharkiv, Ukraine, 61068
Forest Investigative Site 602
Kyiv, Ukraine, 02660
Forest Investigative Site 601
Kyiv, Ukraine, 04080
Forest Investigative Site 612
Kyiv, Ukraine, 04080
Forest Investigative Site 601
Kyiv, Ukraine, 4080
Forest Investigative Site 603
Lviv, Ukraine, 79021
Forest Investigative Site 615
Odesa, Ukraine, 65014
Forest Investigative Site 611
Simferopol, Ukraine, 95006
Forest Investigative Site 617
Ternopil, Ukraine, 46027
Forest Investigative Site 608
Vinnitsa, Ukraine, 21005
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Rui Li Forest Laboratories, Inc. a subsidiary of Actavis plc
  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: July 31, 2014
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
Slovakia: State Institute for Drug Control
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 September 18, 2014