| CTRI Number |
CTRI/2010/091/000140 [Registered on: 23/02/2010] |
| Last Modified On: |
27/08/2013 |
| 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)
|
The purpose of this study is to determine whether cariprazine is safe and effective in the treatment of patients with acute mania associated with Bipolar I disorder. |
Scientific Title of Study
Modification(s)
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A Double-blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| NCT01058096 |
ClinicalTrials.gov |
| RGH-MD-32 |
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
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
Harborside Financial Center, Plaza 5
Jersey City, NJ, USA, 07311
|
| Gedeon Richter Plc. Gyömrői út 19-21. Budapest Hungary 1103 |
|
Primary Sponsor
Modification(s)
|
| Name |
Forest Research Institute |
| Address |
Harborside Financial Center, Plaza 5Jersey City, NJ, USA, 07311 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Quintiles Research India Private Limited |
B-101-106, Shapath IV, Opp. Karnavati Club, Sarkhej – Gandhinagar Road, Ahmedabad 380 051 |
|
Countries of Recruitment
Modification(s)
|
India
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Anjanappa Jagadish |
Abhaya Hospital, Bangalore |
Abhaya Hospital, M.H. Marigowda road,,Wilson Garden-560027
Bangalore
KARNATAKA |
+91 9844059066
91 80 26566767
a_jagadish@yahoo.com |
| Dr. Sanjay Phadke |
Deenanath Mangeshkar Hospital and Research Centre, Pune |
Deenanath Mangeshkar Hospital and Research Centre,Erandawane-411004
Pune
MAHARASHTRA |
+91 9823262786
+91 20 66023105
sanjay_phadke@hotmail.com |
| Dr. Venu Gopal Jhanwar |
Deva Mental Health care, Varanasi |
Deva Mental Health care,B27/70, MN, Durgakund-221005
Varanasi
UTTAR PRADESH |
+91 9936611111
+91 542 2310510
venugj@gmail.com |
| Dr. R. C. Maniar |
Gujarat Institute of Psychological Sciences and Research center, Ahmedabad |
Gujarat Institute of Psychological Sciences and Research center,Shreenath Complex, Opp-punitnagar Society, Umiyavijay Road, Satellite-380015
Ahmadabad
GUJARAT |
+91 9824011933
+91 79 26608498
rcmaniar@yahoo.com |
| Dr. T. S. Sathyanarayana Rao |
J.S.S. Medical College Hospital, Mysore |
J.S.S Medical College Hospital,M.G. Road-570004
Mysore
KARNATAKA |
+91 9845085561
+91 821 2442840
tssrao19@yahoo.com |
| Dr. Sateesh Rao |
K.S. Hegde Medical Academy, Mangalore |
K.S. Hegde Medical Academy,Deralakatte-575018
Bangalore
KARNATAKA |
+91 9845085561
+91 824 2202733
drsateeshrao@yahoo.com |
| Dr. Podila Satya Venkata Narasimha Sharma |
Kasturba Hospital, Manipal |
Kasturba Hospital,-576104
|
+91 820 2922217
+91 820 2571930
psvn.sharma@manipal.edu |
| Dr. R. Sathianathan |
Madras Medical College and Government General Hospital, Chennai |
Madras Medical College and Government General Hospital,Department of Psychiatry-600001
Chennai
TAMIL NADU |
+91 9841019910
+91 44 25384212
sathianathen6@yahoo.com |
| Dr Nadukuru Nooka Raju |
Maharshi Institute of Neuro Psychological Disorders (MIND) |
101 Vishnu Suryaprabha Paradize, KGH Up Road, Maharani Peta, Vishakhapatnam - 530002
Visakhapatnam
ANDHRA PRADESH |
0984-9111505
0891-2724348
drnnraju@yahoo.com |
| Dr. Ramesh Kumar Mahendru |
Mahendru Psychiatric centre, Kanpur |
Mahendru Psychiatric centre,117/40 Sarvodaya Nagar-200005
|
+91 9839032699
+91 512 22420343
rkmahendru@indiatimes.com |
| Dr. Ravish Thunga |
Manaswini Thunga Institute of Psychiatry & Counselling, Mangalore |
Manaswini Thunga Institute of Psychiatry & Counselling,Jyothi Circle, Balmatta-575001
Bangalore
KARNATAKA |
+91 9845263090
+91 824 2445034
ravishthunga@yahoo.com |
| Dr. Jitendra Kumar Trivedi |
Manobal Medical Research Center Pvt Ltd., Lucknow |
Manobal Medical Research Center Pvt Ltd,B-8, Sector-A, Mahanagar-226006
Lucknow
UTTAR PRADESH |
+91 522 2651173
+91 522 2260173
jitendra.trivedi@gmail.com |
| Dr. Mahesh Chudgar |
MITR Foundation, Ahmedabad |
MITR Foundation, 1, Shantinagar society,Ashram road-380013
Ahmadabad
GUJARAT |
+91 9825412109
+ 91 79 27552623
mahesh_mitr@yahoo.co.in |
| Dr. Dattatreya Madhav Dhavale |
Poona Hospital and Research Centre, |
27, Sadashiv Peth, ,-411030
Pune
MAHARASHTRA |
91 9822028286
91 20 24337777
dattatreyad@yahoo.com |
| Dr. Vinay Laxmikantrao Barhale |
Shanti nursing Home, Aurangabad |
Shanti nursing Home, Kanchanwadi, ,Paithan Road-431005
Aurangabad
BIHAR |
+91 9860798041
+91 240 2377631
vinay.barhale@rediffmail.com |
| Dr. Mahesh R. Gowda |
Spandana Nursing Home, Bangalore |
Spandana Nursing Home,Rajajinagar-560010
Bangalore
KARNATAKA |
+91 9845134915
+91 80 23141028
maheshrgowda@yahoo.com |
| Dr. Umesh Nagapurkar |
Sujata Birla Hospital & Medical Research Center, Nasik |
Sujata Birla Hospital & Medical Research Center,Opp. Bytco college-422101
|
+91 9823146088
+91 253 2454254
umeshanjali@gmail.com |
| Dr. Vishal Indla |
Vijayawada Institute of Mental Health and Neurosciences (VIMHANS), Vijayawada |
Vijayawada Institute of Mental Health and Neurosciences (VIMHANS),,V.V. Rao street, Suryarao Pet-520002
|
+91 9704755669
+91 866 2444999
vishalindla@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 18 |
| Name of Committee |
Approval Status |
| Abhaya Ethics Committee, Bangalore- Dr. Anjanappa Jagadish |
Approved |
| Central Ethics Committee - Nittie University, Mangalore- Dr. Satheesh Rao |
Approved |
| DMHC Ethics Committee, Varanasi- Dr. Venu Gopal Jhanwar |
Approved |
| Ethics Committee - J.S.S Medical College Hospital, Mysore- Dr. T. S. Sathyanarayana Rao |
Approved |
| Ethics Committee - Kasturba Hospital, Manipal- Dr. Podila Satya Venkata Narasimha Sharma |
Approved |
| Ethics Committee - MITR Foundation, Ahmedabad- Dr. Mahesh Chudgar |
Approved |
| Ethics Committee - Poona Hospital and Research Centre, Pune- Dr. Dattatreya Madhav Dhavale |
Approved |
| Ethics Committee, Shanti Nursing Home, Aurangabad- Dr. Vinay Laxmikantrao Barhale |
Approved |
| Independent Ethics Committee, Lucknow- Dr. Jitendra Kumar Trivedi |
Approved |
| Institutional Ethics Committee - Andhra Medical College, Vishakhapatnam- Dr Nadukuru Nooka Raju |
Approved |
| Institutional Ethics Committee - Deenanath Mangeshkar Hospital and Research Centre, Pune- Dr. Sanjay Phadke |
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. Umesh Nagapurkar |
Approved |
| Safe Search Independent Ethics Committee, Ahmedabad- Dr. R. C. Maniar |
Approved |
| Spandana Ethics Committee, Bangalore- Dr. Mahesh R. Gowda |
Approved |
| The Ethics Committee - Madras Medical College and Government General Hospital, Chennai - Dr. R. Sathianathan |
Approved |
| VIMHANS-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 Mania associated with Bipolar I Disorder, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Cariprazine |
3-12mg/day Oral Administration |
| Comparator Agent |
Placebo |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(1) Male or female inpatient, 18 to 65 years of age
(2) Patients who have provided informed consent prior to any study specific procedures
(3) Patients currently meeting the DSM-IV-TR criteria for bipolar I disorder as confirmed by the SCID, manic or mixed type with or without psychotic symptoms
(4) Voluntarily hospitalized for current manic episode
|
|
| ExclusionCriteria |
| Details |
(1) Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
(2) Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/ or ECG
|
|
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, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Young Mania Rating Scale (YMRS) |
3 Weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Clinical Global Impression-Severity (CGI-S) |
3 Weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="320"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
20/03/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
09/02/2010 |
| 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 to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder. The study will be a total of 6 weeks in duration: a no-drug screening period of up to 4 to 7 days, followed by 3 weeks of double-blind treatment and a 2-week safety follow-up period. The primary outcome measure is the YMRS and the secondary outcome measure is the CGI-S. This study will be performed at approximately 40 study centers located in and outside the United States. Globally the enrollment target is 320 patients. In India the enrollment target is 160 patients. The date of first patient enrollment in India is March 23, 2010. |