CTRI Number CTRI/2010/091/001400 [Registered on: 01/10/2010]
Last Modified On: 11/07/2017
Post Graduate Thesis No
Type of Trial Interventional
Type of Study
Modification(s)
Drug
Study Design Single Arm Study
Public Title of Study
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Long-term Study of Cariprazine in Patients with Schizophrenia.
Scientific Title of Study
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Evaluation of the Long-Term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia.
Trial Acronym Nil
Secondary IDs if Any
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Secondary ID Identifier
RGH-MD-11; Amendment 1 dated 24 Mar 2010
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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Name Abhishek Das
Designation Sr Clin Project Mgr
Affiliation Quintiles Research India Pvt.
Address Ltd., 2B, Nitesh Broadway,
Phone 08066552035
Fax 08041156255
Email abhishek.das@quintiles.com
Details of Contact Person
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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
Phone 91-7838652395
Fax
Email shoibal.mukherjee@quintiles.com
Details of Contact Person
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
Phone 91-9820712114
Fax 91-22-56774343
Email suchela.srivatsa@quintiles.com
Source of Monetary or Material Support
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Forest Research Institute Harborside Financial Center, Plaza 5 Jersey City, NJ, USA, 07311
Gedeon Richter Plc. Gyömrői út 19-21. Budapest, Hungary 1103
Primary Sponsor
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Name Forest Research Institute
Address Harborside Financial Center, Plaza 5Jersey City, NJ, USA, 07311
Type of Sponsor Pharmaceutical industry-Global
Details of Secondary Sponsor
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Name Address
Quintiles Research India Private Limited
B-101-106, Shapath IV, Opp. Karnavati Club, Sarkhej – Gandhinagar Road, Ahmedabad 380 051
Countries of Recruitment
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India
Sites of Study
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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
+91 79 26577914
Dr. Sateesh Rao
Centre for Psychiatric Research,
Department of Psychiatry, K. S. Hegde Medical Academy, Nitte University, ,Deralakatte, -575 018
+91 9845085561
Dr. Venu Gopal Jhanwar
Deva Mental Health care,
B27/70, MN, ,Durgakund, -221005
+91 9936611111
Dr Nadukuru Nooka Raju
Government Hospital For Mental Care,
Chinawaltair, ,-530017
91-9849111505
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
+91 9824011933
Dr. T. S. Sathyanarayana Rao
J.S.S Medical College and Hospital,
M.G. Road, ,-570004
+91 9845085561
Dr. Rajesh Parikh
Jaslok Hospital and Research Centre,
15, Dr.G. Deshmukh marg, ,-400 026
+91 22 22183908
Dr. Alka Pawar
Maharashtra Institute of Mental Health,
Department of Psychiatry, ,Sassoon General Hospital Campus, Station Road,-411001
+91 9890198453
Dr Ramesh Kumar Mahendru
Mahendru Psychiatric Centre,
117/40 Sarvodaya Nagar, ,-208005
919839032699
Dr. Ravish Thunga
Manaswini, Thunga Institute of Psychiatry & Counselling,
Jyothi Circle, ,Balmatta, -575001
+91 9845263090
Dr. Jitendra Kumar Trivedi
Manobal Medical Research Center Pvt Ltd;
B-8, Sector-A, ,Mahanagar; -226006
+91 522 2651173
Dr. Mahesh Chudgar
MITR Foundation,
1, Shantinagar society, ,Azad sweet shop gully, Ashram road, -380013
+91 9825412109
Dr. Vijay Arachanbhai Nagecha
Nagecha Hospital.
Creative Chamber, ,B/H Bus stand Kanak Road, -360002
+91-9824201520
Dr. Dattatreya Madhav Dhavale
Poona Hospital and Reseach Centre,
27, Sadashiv Peth, ,-411030
+91 9822028286
1. Dr. Vinay Laxmikantrao Barhale
Shanti nursing Home
Kanchanwadi, ,Paithan Road, -431005
+91 9860798041
Dr. Hitendra Gandhi
Sheth V.S. General Hospital,
Ellisbridge, ,-380006
+91-9825066769
Dr. Mahesh R. Gowda
Spandana Nursing Home,
No. 549/46, ,6th Main, 4th Block , Rajajinagar, -560010
+91 9845134915
Dr B S V Prasad
Sujata Birla Hospital & Medical Research Center,
Nasik Poona Highway, ,Opp. Bytco college, -422101
91-9822039737
Dr Vishal Indla
Vijayawada Institute of Mental Health and Neurosciences (VIMHANS),
V.V. Rao street, ,Suryarao Pet, -520002
91-9704755669
Details of Ethics Committee
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No of Ethics Committees= 19
Name of Committee Approval Status
Central Ethics Committee, Nittie University, Medical Sciences Complex, Mangalore- Dr. Satheesh Rao
Approved
DMHC Ethics Committee, Varanasi- Dr. Venu Gopal Jhanwar
Approved
Ethical Committee Sheth V S General Hospital, Ahmedabad- Dr. Hitendra Gandhi
Approved
Ethics Committee - Jagadguru Sri Shivarathreeshwara Medical College, Mangalore- Dr. T. S. Sathyanarayana Rao
Approved
Ethics Committee, MITR Foundation, Ahmedabad- Dr. Mahesh Chudgar
Approved
Ethics Committee, Shanti Nursing Home, Aurangabad- Dr. Vinay Laxmikantrao Barhale
Approved
Ethics Committee- Jaslok Hospital and Research Centre, Mumbai- Dr. Rajesh Parikh
Approved
Ethics Committee; Address: Poona Hospital and Reseach Centre, Pune- Dr. Dattatreya Dhavale
Approved
Independent Ethics Committee, Ahmedabad - Dr. Rohan Kusumgar
Approved
Institutional Ethics Committee, Andhra Medical College, Vishakhapatnam- 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- Dr. B S V Prasad
Approved
Safe Search Independent Ethics Committee, Ahmedabad- Dr. Rajesh C. Maniar
Approved
Shashvat; Address: C/O. Dr. D.K.Shah, Gaurav Fracture and Accident Hospital, Rajkot- Dr. Vijay Nagecha
Approved
Spandana Ethics Committee, Bangalore- Dr. Mahesh R. Gowda
Approved
VIMHANS Hospital Ethics Committee- Dr. Vishal Indla
Approved
Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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Health Type Condition
Patients
Schizophrenia,
Intervention / Comparator Agent
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Type Name Details
Intervention
Cariprazine
oral flexible dose,administration for 48 weeks
Comparator Agent
Nil
Nil
Inclusion Criteria
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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
ExclusionCriteria
Details - Positive result from the blood alcohol test or urine drug screen for prohibited medications
- Patients who have extrapyramidal symptoms that are not adequately controlled by anti-EPS medications in the opinion of the PI
- Patients who are experiencing ongoing, uncontrolled, clinically significant adverse events
Method of Generating Random Sequence
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Not Applicable
Method of Concealment
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Not Applicable
Blinding/Masking
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Open Label
Primary Outcome
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Outcome TimePoints
Safety: - adverse event recording, clinical laboratory parameters, vital signs, electrocardiograms, and other
48 weeks
Secondary Outcome
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Outcome TimePoints
Pharmacokinetics- Plasma concentrations of cariprazine and its metabolites
48 weeks
Target Sample Size
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Total Sample Size= "600"Sample Size from India= "170" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)= ""
Phase of Trial
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Phase 3
Date of First Enrollment (India)
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27/01/2011
Date of Study Completion (India) Date Missing
Date of First Enrollment (Global) 10/05/2010
Date of Study Completion (Global) Date Missing
Estimated Duration of Trial
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Years= "2"Months= "0"Days= "0"
Recruitment Status of Trial (Global)
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Completed
Recruitment Status of Trial (India) Completed
Publication Details
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Not Yet
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
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This is a multinational, multicenter, open-label, flexible-dose, extension study in patients with schizophrenia. The total study duration is 53 weeks: a no-drug screening period of up to 7 days followed by 48 weeks of open-label cariprazine treatment and a 4-week safety follow-up period. The safety assessments include adverse events, clinical laboratory parameters, vital signs, electrocardiogram, ophthalmologic evaluation, extrapyramidal measures, and suicidality. Spontaneous plasma samples will be collected for pharmacokinetic evaluation. Additional outcome measures include Positive and Negative Syndrome Scale, Clinical Global Impressions ? Severity, Schizophrenia Quality of Life Scale Revision 4, and Cognitive Assessments. Approximately 600 patients (approximately 150 in India) are expected to be enrolled in about 100 study centers in the US, India, and other countries. The tentative date of enrollment of first patient in India is September, 2010.
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