| CTRI Number |
CTRI/2026/02/104989 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Metformin as add on therapy to Escitalopram in patients with depressive disorder |
|
Scientific Title of Study
|
METFORMIN AS ADJUNCT THERAPY AND ITS CORRELATION WITH SERUM BDNF LEVELS AND BRAIN NEUROMETABOLITES IN ESCITALOPRAM TREATED MAJOR DEPRESSIVE DISORDER PATIENTS- A 1H-MRS STUDY |
| 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 Jeevana Sai |
| Designation |
Junior Resident, Psychiatry |
| Affiliation |
CENTRAL INSTITUTE OF PSYCHIATRY |
| Address |
Psychiatry department,
Central Institute of Psychiatry, kanke, Ranchi, Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
9490559108 |
| Fax |
|
| Email |
jeevanamanu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sanjay Kumar Munda |
| Designation |
In Charge Centre for Deaddiction Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of Deaddiction psychiatry, Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
8797641082 |
| Fax |
|
| Email |
drsanjaymunda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sanjay Kumar Munda |
| Designation |
In Charge Centre for Deaddiction Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Department of Deaddiction psychiatry, Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
8797641082 |
| Fax |
|
| Email |
drsanjaymunda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, India, 834006 |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, 834006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jeevana Sai |
Central Institute of Psychiatry |
Department of Psychiatry, Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand, 834006
Ranchi
JHARKHAND |
09490559108
jeevanamanu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, CIP, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (2) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (3) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (4) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (5) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (6) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ESCITALOPRAM |
THE ACTIVE CONTROL GROUP WOULD RECEIVE 20MG OF ORAL ESCITALOPRAM ALONE FOR 6 WEEKS |
| Intervention |
METFORMIN ADJUNCT TO ESCITALOPRAM |
THE INTERVENTIONAL GROUP WILL RECEIVE 1000MG OF ORAL METFORMIN AS ADJUNCT TO 2OMG ORAL ESCITALOPRAM FOR 6 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with Major Depressive Disorder according to Diagnostic and Statistical
Manual of Mental Disorders, Fifth Edition (Text Revision), DSM-5-TR Diagnostic criteria.
2. Patients receiving treatment for MDD with stable dose of 20 mg Escitalopram both
on inpatient and outpatient basis.
3. Those who give Informed Consent for participating in the study. |
|
| ExclusionCriteria |
| Details |
1. Any other major co-morbid psychiatric diagnosis and substance dependence excluding
nicotine & caffeine.
2. Major physical illness (uncontrolled Epilepsy, Myocardial Infarction, Uncontrolled
Hypertension, Renal Insufficiency, Liver Failure), Metabolic disorders (Diabetes mellitus,
Hyperlipidaemia) or any Neurological disorders.
3. Pregnant and Lactating Women.
4. Known Hypersensitivity to Metformin.
5. Patient receiving treatment with any other psychotropic medications except
Benzodiazepines.
6. Not willing to give Written Informed Consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement of severity of depression and cognitive functions as measured by rating
scales in MDD patients receiving Metformin as an adjunct to Escitalopram compared
to MDD patients receiving Escitalopram alone. |
primary outcome variables are assessed at baseline, 2 and 6 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Metabolic parameters (BMI, Lipid profile, Waist circumference, FBS)
in MDD patients receiving Metformin as an adjunct to Escitalopram compared to MDD
patients receiving Escitalopram alone. |
secondary outcome variables are assessed at baseline, 2 and 6 weeks after intervention |
Improvement in serum BDNF levels in MDD patients receiving Metformin as an adjunct
to Escitalopram compared to MDD patients receiving Escitalopram alone. |
secondary outcome variables are assessed at baseline, 2 and 6 weeks after intervention |
Alteration in Glu, Gln, NAA concentrations in ACC in MDD patients receiving Metformin
as an adjunct to Escitalopram compared to MDD patients receiving Escitalopram alone. |
secondary outcome variables are assessed at baseline, 2 and 6 weeks after intervention |
Significant correlation between depressive symptoms, cognitive functions, metabolic
parameters, serum BDNF levels and neurometabolite concentrations in patients
receiving Metformin as adjunct to Escitalopram. |
secondary outcome variables are assessed at baseline, 2 and 6 weeks after intervention |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
10/03/2026 |
| 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
|
This study is randomized, parallel group active control study comparing the effectiveness of metformin 1000mg as adjunct to escitalopram in comparison to escitalopram alone in 44 patients both outpatient and inpatient basis at central institute of psychiatry, Ranchi. Primary outcome would be improvement of scores on depressive symptoms and cognitive function tests measured at baseline, 2 and 6 weeks. secondary outcome would be improvement in metabolic parameters, alterations in neurometabolite concentrations and improvement in serum BDNF levels measured at baseline, 2 and 6 weeks |