| CTRI Number |
CTRI/2024/10/075301 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of Metformin in reducing weight gain induced by olanzapine in patients with psychiatric illness. |
|
Scientific Title of Study
|
Metformin for treatment of olanzapine induced weight gain in adult patients with schizophrenia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreeprathap M |
| Designation |
Chairman, Chief psychiatrist and Medical director |
| Affiliation |
Department of psychiatry, Shadithya hospital |
| Address |
Shadithya hospital
No 7,Tannery Street
Pammal road
Pallavaram
Chennai 43
Chennai
TAMIL NADU
600043
India |
| Phone |
9497364991 |
| Fax |
|
| Email |
drsreeprathap@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya R S |
| Designation |
Consultant psychiatrist |
| Affiliation |
Department of psychiatry, Shadithya hospital |
| Address |
Shadithya hospital
Tannery Street
Pammal road
Pallavaram
Chennai
Chennai
TAMIL NADU
600043
India |
| Phone |
9497364991 |
| Fax |
|
| Email |
soumyaramesan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya R S |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Department of psychiatry, Shadithya hospital |
| Address |
Shadithya hospital
Tannery Street
Pammal road
Pallavaram
Chennai
Chennai
TAMIL NADU
600043
India |
| Phone |
9497364991 |
| Fax |
|
| Email |
soumyaramesan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shadithya hospital private limited
No 7 , Tannery Street
Pallavaram
Chennai
Pin 600043
Tamilnadu
India |
|
|
Primary Sponsor
|
| Name |
Shadithya hospital private limited |
| Address |
No 7 Tannery Street
Pammal road
Pallavaram
Chennai
Pin 600043
Tamilnadu
India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dr Sreeprathap M |
Shadithya hospital |
Dr Sreeprathap
Consultation room - 1
First floor - Department of psychiatry
Shadithya hospital
No 7 Tannery Street
Pallavaram
Chennai 600043
Tamilnadu
India
Chennai
TAMIL NADU |
9497364991
drsreeprathap@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee , Indian Medical Association - Tambaram, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metformin |
Metformin will be given to those patients newly started on Olanzapine for the treatment of schizophrenia.
Route of administration - oral
Dosage - 500 to 2000mg/day
Frequency - once or twice a day in divided dosage.
Duration - 3months
Patients will be followed up for 3 months and the parameters like weight, BMI and waist circumference will be measured at specific intervals. The findings of the study will be compared to previous similar studies for comparison. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Schizophrenia and newly started on Olanzapine |
|
| ExclusionCriteria |
| Details |
Patients not tolerating Metformin
Patients with history of renal disease, diabetes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight |
Weight at 15 days, 30 days and 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Waist circumference and Body mass index |
Waist circumference and Body mass index at 15 days, 30 days and 90 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title of the study Metformin for the treatment of olanzapine induced weight gain in adult patients with schizophrenia Objectives of the study To determine the effect of Metformin in reducing Olanzapine-induced weight gain in patients with schizophrenia. To find out the dose range of Metformin which is most effective in reducing weight gain in patients on olanzapine
Study design Observational cohort study Patients with schizophrenia newly started on Olanzapine along with Metformin (500-2000mg/day) Follow up at 15 days, 30 days and 90 days |