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: March 3, 2014
Last verified: March 2014

August 4, 2011
March 3, 2014
August 2011
October 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01412060 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cariprazine Relative to Placebo in the Prevention of Relapse of Symptoms in Patients With Schizophrenia
A Randomized, Double-Blind, Placebo-controlled, Parallel-group Study of Cariprazine(RGH-188) in the Prevention of Relapse in Patients With Schizophrenia

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Schizophrenia
  • 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
  • Drug: Placebo
    Dose-matched placebo, once daily oral administration
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Placebo
  • Experimental: 2
    Cariprazine, 3- 9mg/day (dosage depends on tolerability)
    Intervention: Drug: Cariprazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
November 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Romania,   Slovakia,   Ukraine
 
NCT01412060
RGH-MD-06, 2011-002048-29
No
Forest Laboratories
Forest Laboratories
Gedeon Richter Ltd.
Study Director: Suresh Durgam, MD Forest Laboratories
Forest Laboratories
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP