| CTRI Number |
CTRI/2009/091/000395 [Registered on: 27/07/2009] |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
The purpose of the study is to determine whether Cariprazine is a safe and tolerated long-term treatment in patients with chronic stable schizophrenia. |
Scientific Title of Study
Modification(s)
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A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients With Schizophrenia |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT00839852 |
ClinicalTrials.gov |
| RGH-MD-17 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
|
| Designation |
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| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shoibal Mukherjee |
| Designation |
Vice President, Medical |
| Affiliation |
IQVIA RDS (India) Private Limited |
| 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 |
IQVIA RDS (India) Private Limited |
| Address |
301-A-1, Leela Business Park
MV Road, Andheri East, Mumbai 400059
Mumbai
MAHARASHTRA
400059
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 |
|
Primary Sponsor
Modification(s)
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| Name |
Forest Research Institute Inc |
| Address |
Harborside Financial Center, Plaza V, Jersey City, NJ, USA 07311 |
| Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
Malaysia
Russian Federation
Ukraine
United States of America |
Sites of Study
Modification(s)
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| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. A. Jagadish |
Abhaya Hospital, |
No. 17, Dr. M. H. Marigowda Road, ,Wilson Garden, -560 027
Bangalore
KARNATAKA |
91-80-26564586/26563865
080-26566767
a_jagadish@yahoo.com |
| Dr. Sanjay Phadke |
Deenanath Mangeshkar Hospital & Research Centre, |
Erandwane, ,-411 004
Pune
MAHARASHTRA |
91-20 -26050550, Ext. 3153
91-20-25420104
sanjay_phadke@hotmail.com |
| Dr. N N Raju |
Government Hospital for Mental Care, |
Department of Psychiatry, ,China Waltair, -530017
Visakhapatnam
ANDHRA PRADESH |
91 98856 17828
drnnraju@yahoo.com |
| Dr. Pradip Vaghasiya |
Gujarat Institute of Psychological Sciences and Research (GIPS), |
Satellite Hospital, ,Umiya Vijay Society Road, -380015
Ahmadabad
GUJARAT |
91 98797 87020
079-26608498
pradip.gips@yahoo.com |
| Dr. Satyanarayan Rao |
JSS Medical College Hospital, |
Dept. Psychiatry, ,Ramanuja Road, -570004
Mysore
KARNATAKA |
91 821 2442840
0821-2442840
tssrao19@gmail.com |
| Dr PSVN Sharma |
Kasturba Hospital, |
Department of Psychiatry, ,-576 104
|
91-9880703807
0820-2571930
prvn.sharma@mainpal.edu |
| Dr. Keshava Pai |
Kasturba Medical College & Hospital (KMH), |
Attavar, ,-575 001
Bangalore
KARNATAKA |
91 94481 05227
0824-2425092
paikeshava@hotmail.com |
| Dr. R. K. Mahendru |
Mahendru Psychiatric Centre, |
117/40, ,Sarvodayanagar, -208005
|
91-0512-2256900 /2233838 /3095657 /32905667
91-0521-2548201/2242034
rkmahendru@indiatimes.com |
| Dr. Mahesh Chudgar |
Mental Illness Treatment Rehabilitation Foundation (MITR), |
1, Shantinagar Society, ,Azad Sweet Shop Gully, Juna Vadaj, -380 013
Ahmadabad
GUJARAT |
079 2755 3123
079 2755 3123
chudgarpsych@icenet.net |
| Dr. Rakesh Yadav |
R.K.Yadav Memorial Mental Health & De-Addiction Hospital |
B-6, Hanuman Nagar ,Main Sirsi Road, Khatipura-302021
Jaipur
RAJASTHAN |
91 93511 57584
91 141 2350492
drrakeshyadav@hotmail.com |
| Dr. T. P. Sudhakar |
Sri Venkateswara Medical College |
Dept. of Psychiatry, ,-517507
|
91 98490 47503
0877-2286499/ 0877 2286568
sudhakartp@gmail.com |
| Dr. Vishal Indla |
Vijayawada Institute of Mental Health and Neurosciences |
29-7-32, ,V.V. Rao Street -520002
|
91 866 2432040
91 866 2432040
vishalindla@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Abhaya Ethics Committee, Bangalore- Dr. A. Jagdish |
Approved |
| Ethics Committee, MTRI Hospital,Mental Illness Treatment Rehabilitation Foundation (MITR), Ahmedabad - Dr. Mahesh Chudgar |
Approved |
| Instituitional Ethics Committee, Andhra Medical College, Visakhapatnam- Dr. N. N. Raju |
Approved |
| Instituitional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre, Pune- Dr. Sanjay Phadke |
Approved |
| Institutional Ethics Committee, Jagadguru Sri Shivarathreeshwara Medical College, Mysore- Dr. T. S. Sathyanarayan Rao |
Approved |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore- Dr. Keshava Pai |
Approved |
| Institutional Ethics Committee, Tirupati- Dr. T. P. Sudhakar |
Approved |
| Kasturba Hospiatl Ethics Committee, Kasturba Hospital, Manipal - Dr P S V N Sharma |
Approved |
| Mahendru Psychiatric Center Ethics Committee, Mahendru Psychiatric Centre, Kanpur- Dr. R. K. Mahendru |
Approved |
| National Ethics Committee, Gujarat Institute of Psychological Sciences and Research (GIPS), Ahmedabad-Dr. Pradip Vaghasiya |
Approved |
| R K Yadav Ethics Committee, R.K.Yadav Memorial Mental Health & De-Addiction Hospital, Jaipur- Dr. R. K. Yadav |
Approved |
| VINHAMS Ethics Committee, Vijayawada Institute of Mental Health and Neurosciences, Vijayawada- Dr. Vishal Indla |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
Schizophrenia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
RGH-188 (Cariprazine) |
Duration of treatment: 48 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
- Patients who have completed the double-blind treatment period of the lead-in study (RGH-MD-16)
- Patients who have responded to double-blind treatment in the lead-in study as outpatients (As demonstrated by at least a 20% reduction in PANSS total score relative to Visit 2 of the lead-in study and a CGI-S score of less than or equal to 3)
- Patients eligible to continue as outpatients based on the opinion of the Principal Investigator
- Patients must have a caregiver to ensure treatment compliance
|
|
| ExclusionCriteria |
| Details |
- Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/ or ECG |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
- Clinical laboratory
- Electrocardiogram
- Adverse events
- Physical Examinations
- Extrapyramidal symtomatology |
During conduct of the study |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Not applicable |
Not Applicable |
|
Target Sample Size
Modification(s)
|
Total Sample Size="250"
Sample Size from India="125"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
20/06/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
05/03/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
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This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with Schizophrenia. Study Methodology: International, multicenter, open-label, flexible dose, extension to study RGH-MD-16 (lead-in study) a randomized, double-blind, active controlled, parallel group study in patients with acute exacerbation of schizophrenia. The primary outcomes measures of the study includes: Clinical laboratory, Electrocardiogram, Adverse events, Physical Examinations and Extrapyramidal symptomatology. In India, we are planning to enroll approximately 125 patients. The first patient screening date in India was June 20, 2009. |