Health Condition 1: null- MAJOR DEPRESSIVE DISORDER
Conditions
Interventions
Intervention1: TABLET AGOMELATINE 25mg AT BEDTIME: TABLET AGOMELATINE 25mg AT BEDTIME WILL BE GIVEN ORALLY 30 MINUTES AFTER FOOD FOR 6 WEEKS DURATION.
Control Intervention1: TABLET AMITRIPTYLINE 75mg
Sponsors
MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
Dr BM PARASHIVAMURTHY
Dr RAVEESH BN
Eligibility
Inclusion criteria
Inclusion criteria: • Subjects diagnosed with major depressive disorder, single episode- according to Diagnostic and Statistical Manual of Mental disorders 5 (DSM 5) criteria. • Age between 18 - 60 years. • Subjects who give informed consent.
Exclusion criteria
Exclusion criteria: • Subjects with history of bipolar disorder, schizophrenia, schizoaffective disorder. • Subjects with suicidal tendencies. • Subjects with altered liver function. • Subjects with any serious concurrent illness. • Presence of organic brain syndrome (delirium, dementia). • Presence of alcohol and substance abuse/dependence, epilepsy, mental retardation, pregnancy and lactation. • Subjects who are on antidepressant medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. BECKS DEPRESSION INVENTORY II SCORE 2. CLINICAL GLOBAL IMPRESSION- SEVERITY SCORE 3. QUALITY OF SLEEP USING LEEDS QUESTIONNAIRE 4. ESTIMATION OF LIVER ENZYMES: SGPT AND SGOT 5. BODY MASS INDEX Timepoint: DONE AT BASELINE ( BEFORE MEDICATION ), 2ND WEEK AND 6TH WEEK | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.CLINICAL GLOBAL IMPRESSION- IMPROVEMENT SCORE 2.ADVERSE DRUG EFFECTS USING UKU SIDE EFFECT SCALE 3.MEDICATION COMPLIANCETimepoint: DONE AT 2ND WEEK AND 6TH WEEK | — |
Countries
India
Contacts
Public ContactDr MAMATHA V
MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
Outcome results
None listed