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CTRI Number  CTRI/2022/04/041843 [Registered on: 13/04/2022] Trial Registered Prospectively
Last Modified On: 08/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects and safety of two drugs, Lurasidone and olanzapine in patients with Schizophrenia  
Scientific Title of Study   A comparative study to assess the effectiveness and cardio-metabolic safety profile of Lurasidone versus Olanzapine in patients with Schizophrenia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Alok Gupta 
Designation  Post Graduate Trainee 
Affiliation  IMS SUM Hospital 
Address  Department of Psychiatry, IMS SUM Hospital, Kalinga Nagar
K8/14, Mouza Ghatikia, Kalinga Nagar
Khordha
ORISSA
751003
India 
Phone  8840236928  
Fax    
Email  dralokgupta90@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Suvendu Narayan Mishra 
Designation  Professor 
Affiliation  IMS SUM Hospital 
Address  Department of Psychiatry, IMS SUM Hospital, Kalinga Nagar

Khordha
ORISSA
751003
India 
Phone  9861273580  
Fax    
Email  dr.sar07@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Alok Gupta 
Designation  Post Graduate Trainee 
Affiliation  IMS SUM Hospital 
Address  Department of Psychiatry, IMS SUM Hospital, Kalinga Nagar
K8/14, Mouza Ghatikia, Kalinga Nagar
Khordha
ORISSA
751003
India 
Phone  8840236928  
Fax    
Email  dralokgupta90@yahoo.com  
 
Source of Monetary or Material Support  
IMS SUM Hospital, Kalinga Nagar, Bhubaneswar, Odisha 751003 
 
Primary Sponsor  
Name  Alok Gupta 
Address  IMS SUM Hospital, Kalinga Nagar, Bhubaneswar, Odisha 751003 
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Alok Gupta  IMS SUM Hospital  Basement 1, Department of Psychiatry, Kalinga Nagar, Bhubaneswar 751003
Khordha
ORISSA 
8840236928

dralokgupta90@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IMS SUM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F20||Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lurasidone  40mg-160mg, once daily dosage and oral intake for 6 weeks. 
Comparator Agent  Olanzapine  5mg-20mg, once daily dosage, oral intake for 6 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients giving informed consent, diagnosed with Schizophrenia as per ICD 10 diagnostic criteria and drug free for atleast 8 weeks. 
 
ExclusionCriteria 
Details  Known case of diabetes mellitus, dyslipidemia and cardiac illness. Systemic or neurological Disorder affecting cognition, behavior or mental status.
Substance dependence except nicotine and caffeine within the past month of entering the study.Long standing medical or surgical illness and patients with mental retardation or organic brain disease.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Positive and Negative Syndrome Scale, Brief Psychiatric Rating Scale, Clinical Global Impressions Scale – Impressions and Montreal Cognitive Assessment would be used to assess change in symptoms of Schizophrenia.  At the time of enrollment in the study and at the end of 6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Lipid Profile, Fasting Blood Sugar, Post Postprandial Blood Sugar and ECG would be done to assess change in cardio metabolic parameters in the patients.  At the time of enrollment in the study and at the end of 6 weeks. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="114" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/04/2022 
Date of Study Completion (India) 31/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a randomized, single blind, parallel group, single-centre trial comparing the effectiveness and cardio metabolic safety of Lurasidone and olanzapine for 12 months in 120 patients with Schizophrenia that will be conducted in India. The primary outcome measures will be Positive and Negative Syndrome Scale, Brief Psychiatric Rating Scale and Clinical Global Impressions Scale – Impressions at 6 weeks. The secondary outcomes will be Lipid Profile, Fasting Blood Sugar, Post Prandial Blood Sugar and ECG at 6 weeks.   
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