Health Condition 1: F329- Major depressive disorder, singleepisode, unspecified
Conditions
Interventions
Control Intervention1: Nil: Nil
Sponsors
Dr Avinash V Turankar
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients above 18 years of age, of either gender. 2) Patients with clinically diagnosed major depressive disorder by psychiatrist as per the DSM 5 TR criteria and a HAM-D scale score more or equal to 19. 3) Known MDD patients who have not taken any medication for last 1 month. 4) Patients willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with history of addiction. 2) Patients with any other long-term treatment like anti-hypertensive, anti-diabetic, anti-tubercular drugs. 3) Patients with neurological disorders (dementia, stroke, seizures), obesity with functional impairment, serious or not stabilized organic brain disorder. 4) Pregnant and lactating women. 5) Known patients of MDD on regular treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Difference in mean change in the Hamilton Depression Rating Scale (HAM-D) from baseline to the end of the 12-weeks. 2)Difference in mean change in the Beck s Depression Inventory (BDI) scores from baseline to the end of the 12-weeks. Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Safety evaluation done by recording and evaluating the adverse events reported by patients. 2) Quality of life evaluation using WHOQOL BREF self-report questionnaire Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks. | — |
Countries
India
Contacts
Public ContactDr Avinash V Turankar
Government Medical College, Nagpur
Outcome results
None listed