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Safety and Efficacy of Cariprazine in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Gedeon Richter Ltd.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01104779
First received: April 14, 2010
Last updated: December 6, 2012
Last verified: December 2012
History of Changes

April 14, 2010
December 6, 2012
April 2010
December 2011   (final data collection date for primary outcome measure)
Measurement of schizophrenia symptoms: Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01104779 on ClinicalTrials.gov Archive Site
Measurement of schizophrenia symptoms: Clinical Global Impression-Severity (CGI-S) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Cariprazine in Schizophrenia
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Cariprazine
    Patients who meet eligibility criteria will be administered a once daily oral low dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
    Other Name: RGH-188
  • Drug: Cariprazine
    Patients who meet eligibility criteria will be administered a once daily oral high dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
    Other Name: RGH-188
  • Drug: Placebo
    Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
  • Experimental: 1
    Cariprazine once daily fixed-flexible low dose
    Intervention: Drug: Cariprazine
  • Experimental: 2
    Cariprazine once daily fixed-flexible high dose
    Intervention: Drug: Cariprazine
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
459
December 2011
December 2011   (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 (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
  • Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

  • Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Colombia,   India,   South Africa
 
NCT01104779
RGH-MD-05
No
Forest Laboratories
Forest Laboratories
Gedeon Richter Ltd.
Study Director: Raffaele Migliore, MA Forest Laboratories
Forest Laboratories
December 2012

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