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

This study is currently recruiting participants.

Verified June 2013 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: June 12, 2013

Last verified: June 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 4, 2011

Last Updated Date

June 12, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01412060 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-controlled, Parallel-group Study of Cariprazine(RGH-188) in the Prevention of Relapse in Patients With Schizophrenia

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

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

Study Arm (s)

Placebo Comparator: 1
Placebo

Intervention: Drug: Placebo
Experimental: 2
Cariprazine, 3- 9mg/day (dosage depends on tolerability)

Intervention: Drug: Cariprazine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

900

Estimated Completion Date

November 2014

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sandra Beaird, Pharm.D

1-800-678-1605 ext 66297

FRXClinTrials@frx.com

Location Countries ^ICMJE

United States, India, Romania, Slovakia, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT01412060

Other Study ID Numbers ^ICMJE

RGH-MD-06, 2011-002048-29

Has Data Monitoring Committee

Responsible Party

Forest Laboratories

Study Sponsor ^ICMJE

Forest Laboratories

Collaborators ^ICMJE

Gedeon Richter Ltd.

Investigators ^ICMJE

Study Director:

Suresh Durgam, MD

Forest Laboratories

Information Provided By

Forest Laboratories

Verification Date

June 2013

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

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