Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features Health Condition 2: F330- Major depressive disorder, recurrent, mild Health Condition 3: F331- Major depressive disorder, recurrent, moderate Health Condition 4: F320- Major depressive disorder, singleepisode, mild Health Condition 5: F321- Major depressive disorder, singleepisode, moderate Health Condition 6: F322- Major depressive disorder, singleepisode, severe without psychotic features
Conditions
Interventions
Intervention1: METFORMIN ADJUNCT TO ESCITALOPRAM: THE INTERVENTIONAL GROUP WILL RECEIVE 1000MG OF ORAL METFORMIN AS ADJUNCT TO 2OMG ORAL ESCITALOPRAM FOR 6 WEEKS
Control Intervention1: ESCITALOPRAM: T
Sponsors
Central Institute of Psychiatry
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: primary outcome variables are assessed at baseline, 2 and 6 weeks after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: secondary outcome variables are assessed at baseline, 2 and 6 weeks after intervention | — |
Countries
India
Contacts
Public ContactProf Dr Sanjay Kumar Munda
Central Institute of Psychiatry
Outcome results
None listed