A clinical trial to study effect of Cariprazine in Patients With Schizophrenia
Scientific Title of Study
A randomized, double-blind, placebo-controlled, parallel-group study of Cariprazine (RGH-188) in the prevention of relapse in patients with schizophrenia
Manipal University Ethics Committee,Manipal -576104 - Dr. PSVN Sharma
Approved
North Maharashtra Ethics Committee,432 B Dr. Kulkarni Nursing Home, Vakilwadi, Nashik - 422101 - Dr. BSV prasad
Approved
Safe Search Independent Ethics Committee, Siddhachal Complex, Near Doordarshan Kendra, Thaltej, Ahmedabad – 380054 - Dr. R C Maniar
Approved
The Ethics Committee,R.K. Yadav Memorial Mental Health & De-addiction Hospital,B-6, Hanuman Nagar, Main Sirsi Road, Khatipura,Jaipur - 302021 - Dr. Rakesh Yadav
Approved
Vijayawada Institute of Mental Health and Neuro Sciences (VIMHANS) Ethics Committee, 29-7-32, V.V. Rao Street, Suryaraopet, Vijayawada – 520002 - Dr. Vishal Indla
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Schizophrenia,
Intervention / Comparator Agent
Type
Name
Details
Intervention
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 for 92 weeks
Comparator Agent
Placebo
Dose-matched placebo, once daily oral administration for 92 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
•Patients who have provided informed consent prior to any study specific procedures
•Current diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria as determined by the Structured Clinical Interview for DSM-IV (SCID)
•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
ExclusionCriteria
Details
•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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Time from baseline to the first symptom relapse during the Double-Blind phase
At 20 Weeks and Bi-Weekly thereafter until week 92
Secondary Outcome
Outcome
TimePoints
Time from baseline to the first symptom relapse during the Double-Blind phase
At 20 Weeks and Bi-Weekly thereafter until week 92
Target Sample Size
Total Sample Size="900" Sample Size from India="270" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This 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.
The primary outcome measures will be time from baseline to the first symptom relapse during the Double-Blind phase.
Globally, this study is proposed to be conducted in 09 countries including USA, Ukraine, Bulgaria, Argentina, Romania, Slovakia and India.
We propose to conduct the referenced study on 270 enrolled subjects and 54 randomized subjects at 22 study centers in India, out of 900 planned subjects to be screened, approximately 450 will be enrolled in the open-label Run-In Phase; with approximately 180 randomized patients during the Double-Blind Phase globally.
The tentative date of enrollment of first patient in India is April 01, 2012.