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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:
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
History of Changes
  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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

Contacts
Contact: Sandra Beaird, PhD 1-800-678-1605 ext 66297 info@forestpharm.com

  Show 57 Study Locations
Sponsors and Collaborators
Forest Laboratories
Gedeon Richter Ltd.
Investigators
Study Director: Suresh Durgam, MD Forest Laboratories
  More Information

Additional Information:
Potential Clinical Trial Investigator Survey  This link exits the ClinicalTrials.gov site

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 16, 2013