FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2010/091/000663 [Registered on: 30/06/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, asenapine and risperidone in the acute treatment of schizophrenia. 
Scientific Title of Study   Evaluation of efficacy and safety of asenapine versus risperidone in the acute treatment of schizophrenia: a randomized, open label, active controlled, multicentric study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
SUN/ASERIS/1009  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Surendra Borgharkar 
Designation   
Affiliation   
Address  Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East
Mumbai
MAHARASHTRA
400059
India 
Phone  02266969696  
Fax  02228212010  
Email  medical.services@sunpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Surendra Borgharkar 
Designation   
Affiliation   
Address  Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East
Mumbai
MAHARASHTRA
400059
India 
Phone  02266969696  
Fax  02228212010  
Email  medical.services@sunpharma.com  
 
Details of Contact Person
Public Query  
Name  Dr. Surendra Borgharkar 
Designation   
Affiliation   
Address  Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East
Mumbai
MAHARASHTRA
400059
India 
Phone  02266969696  
Fax  02228212010  
Email  medical.services@sunpharma.com  
 
Source of Monetary or Material Support  
Sun Pharmaceutical Industries Ltd. 
 
Primary Sponsor  
Name  Sun Pharmaceutical Industries Ltd., ACME Plaza, Andheri Kurla Road (E), Mumbai - 400059. India. 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. P. C. Shastri  Dr. Shastri?s Clinic  Vivina Co. Op. Hous. Society,Block no. 3, Building no 3, S. V. Road, Opp. Andheri Station, Andheri (w)-400058
Mumbai
MAHARASHTRA 

pcs910@hotmail.com, drs329@hotmail.com 
Dr. Nitin Dalaya  Nityanand Rehabilitation & Residential Mental Health Care Centre  Behind Bharti Vidyapeeth, Inside Patang Plaza,Opp Sachi-Aai Mata Mandir, Katraj-411046
Pune
MAHARASHTRA 

nitin.dalaya@rediffmail.com , nityanand_dal@rediffmail.com 
Dr. Lakshman Dutt  Shri Krishnaprasad Psychiatric Nursing Home  2nd Floor, Narnarayan Palace, Near Kochrab Ashram,Opp. Dipak Petrol Pump, Pritamnagar, Ellisbridge-380006
Ahmadabad
GUJARAT 

lakshmandutt1@indiatimes.com, lakshmandutt1@yahoo.in 
Dr. P. M. Chougule  Swastik Hospital  143 A/12, Plot No. 6 E, Behind Nashte Estate,Near Mahavir Garden, Assembly Road-416001
Kolhapur
MAHARASHTRA 

kpr_paris@sancharnet.in, kpr_pmchougule@data1.in 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
COMSARTs Independant Ethics Committee for Dr. Lakshman Dutt  Approved 
COMSARTs Independant Ethics Committee for Dr. Nitin Dalaya  Approved 
COMSARTs Independant Ethics Committee for Dr. P. C. Shastri  Approved 
COMSARTs Independant Ethics Committee for Dr. P. M. Chougule  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  In the acute treatment of schizophrenia.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Asenapine  5 mg twice daily 
Comparator Agent  Risperidone  2 mg to 8 mg per day 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1. Male or female patients aged between 18 and 65 years. 2. Has a primary diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV TR). 3. Patient willing to give their informed consent.  
 
ExclusionCriteria 
Details  1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control. 2. Patients having hypersensitivity to Investigational products. 3. Patients having untreated or clinically significant renal, endocrine, hepatic, respiratory diseases. 4. Patients with a history of neurologic illness. 5. Patients who displayed marked suicidal intent or known suicidal tendencies. 6. Alcohol abused patients.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Average change in total score of Positive Symptoms and Negative Symptoms using PANSS.  Day 0, Day 14, Day 42 
 
Secondary Outcome  
Outcome  TimePoints 
1. Average change from baseline to end of trial in Clinical Global Impression on Severity (CGI-S). 2. Clinical Global Impression on Improvement (CGI-I) in patients.   1. Day 0, Day 42, 2. Day 14, Day 42  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/07/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a randomized, open label, active controlled, multicentric study comparing the safety and efficacy of asenapine 5 mg twice daily and Risperidone once or twice daily for 6 weeks in 200 patients with schizophrenia that will be conducted in four centers in India only. The primary outcome measures will be average change in total score of Positive Symptoms and Negative Symptoms using PANSS. The secondary outcomes will be assessment of CGI-S at day 0 and day 42 and assessment of CGI-I at day 14 and day 42. The anticipated date of enrollment will be 7th July 2010, subject to registration at CTRI. This is not a global trial. 
Close