| CTRI Number |
CTRI/2010/091/001068 [Registered on: 04/10/2010] |
| Last Modified On: |
05/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Safety and Efficacy of Cariprazine in Schizophrenia. |
Scientific Title of Study
Modification(s)
|
A Double-blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT01104779 |
ClinicalTrials.gov |
| RGH-MD-05 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shoibal Mukherjee |
| Designation |
Vice President, Medical |
| Affiliation |
Quintiles Research (India) Pvt. Ltd. |
| Address |
8th Floor, DLF Square
M Block, Jacaranda Marg
DLF City Phase II
Gurgaon, Haryana
India - 122002
Gurgaon
HARYANA
122002
India |
| Phone |
91-7838652395 |
| Fax |
|
| Email |
shoibal.mukherjee@quintiles.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Suchela Srivatsa |
| Designation |
Director – Clinical Operations |
| Affiliation |
Quintiles Research (India) Pvt. Ltd. |
| Address |
301-A-1, Leela Business Park
MV Road, Andheri East, Mumbai 400059
Mumbai
MAHARASHTRA
400 059
India |
| Phone |
91-9820712114 |
| Fax |
91-22-56774343 |
| Email |
suchela.srivatsa@quintiles.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Forest Research Institute, Inc.,
Harborside Financial Center, Plaza V,
Jersey City, NJ, USA, 07311
Gedeon Richter Plc.
Gyömrői út 19-21.
Budapest, Hungary 1103
|
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Primary Sponsor
Modification(s)
|
| Name |
Forest Research Institute Inc |
| Address |
Harborside Financial Center, Plaza V,Jersey City, NJ, USA, 07311 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Quintiles Research India Pvt Ltd |
B-101-106, Shapath IV, Opp. Karnavati Club, Sarkhej – Gandhinagar Road, Ahmedabad 380 051 |
|
Countries of Recruitment
Modification(s)
|
India
Colombia
South Africa
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 19 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rohan D. Kusumgar |
Aashray Clinic |
114, Span Trade Centre, Opposite Kocharab Aashram,N-Paldi Cross Road, Ellisbridge-380006
Ahmadabad
GUJARAT |
079 26577914
079 26577914
dr_rohan291@rediffmail.com |
| Dr. Sateesh Rao |
Centre for Psychiatric Research |
department of Psychiatry, K. S. Hegde Medical Academy,Nitte University, Deralakatte-575 018
Bangalore
KARNATAKA |
09845085561
0824 2202733
drsateeshrao@yahoo.com |
| Dr. Venu Gopal Jhanwar |
Deva Mental Health care |
B27/70, MN,Durgakund-221005
Varanasi
UTTAR PRADESH |
09936611111
0542 2310510
venugj@gmail.com |
| Dr. Nadukuru Nooka Raju |
Government Hospital For Mental Care |
Chinawaltair,-530017
|
09849111505
0891 2724348
drnnraju@yahoo.com |
| Dr. R C Maniar |
Gujarat Institute of Psychological Sciences and Research center (GIPS) |
Shreenath Complex, Umiya Vijay road,Opp Punit nagar-1 Society, Satellite-380015
Ahmadabad
GUJARAT |
09824011933
079-26608498
rcmaniar@yahoo.com |
| Dr. T. S. Sathyanarayana Rao |
J.S.S Medical College and Hospital |
M.G. Road,-570004
Mysore
KARNATAKA |
09845085561
0821 2442840
tssrao19@yahoo.com |
| Dr. Rajesh Parikh |
Jaslok Hospital and research Centre |
15, Dr.G. Deshmukh marg,-400 026
Mumbai
MAHARASHTRA |
022-22183908
022-23510515
dr.rmparikh@gmail.com |
| Dr. Alka Pawar |
Maharashtra Institute of mental health |
Department of psychiatry,Sassoon General Hospital Campus,Station Road-411001
Pune
MAHARASHTRA |
09890198453
020-26123738
alkavpawar@yahoo.com |
| Dr. Ramesh Kumar Mahendru |
Mahendru Psychiatric centre |
117/40 Sarvodaya Nagar,-208005
|
09839032699
0512 22420343
rkmahendru@indiatimes.com |
| Dr. Ravish Thunga |
Manaswini, Thunga Institute of Psychiatry & Counselling |
Jyothi Circle,Balmatta-575001
Bangalore
KARNATAKA |
09845263090
0824 2445034
ravishthunga@yahoo.com |
| Dr. Jitendra Kumar Trivedi |
Manobal Medical Research Center Pvt Ltd |
B-8, Sector-A,Mahanagar-226006
Lucknow
UTTAR PRADESH |
0522 2651173
0522 2260173
jitendra.trivedi@gmail.com |
| Dr. Mahesh Chudgar |
MITR Foundation, |
1, Shantinagar society, Azad sweet shop gully,-380013
Ahmadabad
GUJARAT |
09825412109
079 27552623
mahesh_mitr@yahoo.co.in |
| Dr. Vijay Arachanbhai Nagecha |
Nagecha Hospital |
Creative Chamber,B/H Bus stand Kanak Road-360002
Rajkot
GUJARAT |
09824201520
0281-2222224
nagecha@rediffmail.com |
| Dr. Dattatreya Madhav Dhavale |
Poona Hospital and Reseach Centre |
27, Sadashiv Peth,-411030
Pune
MAHARASHTRA |
09822028286
020 24337777
dattatreyad@yahoo.com |
| Dr. Vinay Laxmikantrao Barhale |
Shanti nursing Home |
Kanchanwadi, Paithan Road,,-431005
Aurangabad
BIHAR |
09860798041
0240 2377631
vinay.barhale@rediffmail.com |
| Dr. Hitendra Gandhi |
Sheth V.S. General Hospital |
Ellisbridge,-380006
Ahmadabad
GUJARAT |
09825066769
079-26579668
hitengandhi@yahoo.co. |
| Dr. Mahesh R. Gowda |
Spandana Nursing Home |
No. 549/46, 6th Main, 4th Block,Rajajinagar-560010
Bangalore
KARNATAKA |
09845134915
080 23141028
maheshrgowda@yahoo.com |
| Dr. B S V Prasad |
Sujata Birla Hospital & Medical Research Center |
Nasik Poona Highway,Opp. Bytco college-422101
|
09822039737
0253-2461324
bsvprasad2@gmail.com |
| Dr. Vishal Indla |
Vijayawada Institute of Mental Health and Neurosciences (VIMHANS) |
V.V. Rao street,Suryarao Pet-520002
|
09704755669
0866 2444999
vishalindla@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 19 |
| Name of Committee |
Approval Status |
| Central Ethical Committee, Nittie University, Medical Sciences Complex, Deralakatte, Mangalore- Dr. Satheesh Rao |
Approved |
| DMHC Ethics Committee, Varanasi- Dr. Venu Gopal Jhanwar |
Approved |
| Ethical Committee Sheth V S General Hospital, Ellisbridge, Ahmedabad- Dr. Hitendra gandhi |
Approved |
| Ethics Committee - Jagadguru Sri Shivarathreeshwara Medical College, Mysore |
Submittted/Under Review |
| Ethics Committee, Jaslok Hospital and research Centre, Mumbai- Dr. Rajesh Parikh |
Approved |
| Ethics Committee, MITR Foundation; Ashram road, Ahmedabad- Dr. mahesh Chadgar |
Approved |
| Ethics Committee, Shanti Nursing Home; Address: Kanchanwadi, Paithan Road, Aurangabad-431005- Dr. Vinay Laxmirao Barhale |
Approved |
| Ethics Committee; Address: Poona Hospital and Reseach Centre, Sadashiv Peth, Pune- Dr. Dattatreya Dhavale |
Approved |
| Independent Ethics Committee, Ahmedabad- Dr. Rohan Kasumgar |
Approved |
| Institutional Ethics Committee, Andhra Medical College, Vishakhapatnam, Andhra Pradesh- Dr. N. N. Raju |
Approved |
| Institutional Ethics Committee, Maharashtra Institute of Mental Health, Pune- Dr. Alka Pawar |
Approved |
| Lucknow Ethics Committee, Lucknow- Dr. Jitendra Kumar Trivedi |
Approved |
| Mahendru Psychiatric Centre Ethics Committee, Kanpur- Dr. Ramesh Kumar Mahendru |
Approved |
| Mallikatta Ethical Committee, Mangalore- Dr. Ravish Thunga |
Approved |
| North Maharashtra Ethics Committee, Nasik, Maharashtra |
Submittted/Under Review |
| Safe Search Independent Ethics Committee, Thaltej, Ahmedabad |
Submittted/Under Review |
| Shashvat Independent Ethics Committee, Gaurav Fracture and Accident Hospital, Rajkot- Dr. Vijay Negecha |
Approved |
| Spandana Ethics Committee, Rajajinagar, Bangalore- Dr. Mehash R. Gowda |
Approved |
| VIMHANS Hospital Ethics Committee, Vijayawada - Dr. Vishal Indla |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute Schizophrenia, (1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Cariprazine |
Cariprazine once daily fixed-flexible high dose, oral administration for 6 weeks |
| Intervention |
Cariprazine |
Cariprazine once daily fixed-flexible low dose, oral administration for 6 weeks; |
| Comparator Agent |
Placebo |
once daily oral administration for 6 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patients who are 18 to 60 years of age
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)
|
|
| ExclusionCriteria |
| Details |
Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Measurement of schizophrenia symtopms: Positive and Negative Syndrome Scale (PANSS) total score, |
6 Weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Measurement of schizophrenia symtopms: Clinical Global Impression-Severity (CGI-S) |
6 Weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="450"
Sample Size from India="170"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/12/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
27/04/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed/flexible-dose study in adult patients with a primary diagnosis of schizophrenia. The total study duration is 9 weeks: a no-drug screening period of up to 7 days, followed by 6 weeks of double-blind treatment and a 2-week safety follow-up period. At the end of the screening period, patients meeting eligibility criteria will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio: placebo, cariprazine 3 to 6 mg/day, or cariprazine 6 to 9 mg/day. This study will be performed at approximately 40 study centers in the US, India, and other countries. A total of 450 patients (approximately 170 patients in India) are planned to be randomized in this study. The primary outcome measure is the PANSS and the secondary outcome measure is the CGI-S. The tentative date for patient enrollment at an Indian site is in last week of October, 2010. |