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
|
|
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
|
|
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.
|