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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: October 31, 2014
Last verified: October 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 ]

Enrollment: 766
Study Start Date: August 2011
Estimated Study Completion Date: November 2014
Primary Completion Date: August 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

  Show 77 Study Locations
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: October 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
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 25, 2014