Health Condition 1: F321- Major depressive disorder, singleepisode, moderate
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Drug naïve patients of either gender having age between 18 to 70 years with a clinical diagnosis of depressive episode as per ICD 10 (F 32) 2. Hamilton Scale of Rating Depression (HAM-D) score >20; 3. Baseline Hamilton Anxiety Rating Scale (HAM-A) score > 14
Exclusion criteria
Exclusion criteria: 1. Subjects with other coexistent psychiatric disorders as described by ICD 10, (World Health Organization, 2008) 2. Subjects on antianxiety medication within washout period 3. Use of psychoactive substances except tobacco and caffein 4. Concurrent debilitating illnesses like chronic renal failure, malignancy, cirrhosis etc 5. Subjects on drugs which are known to interact with the study medications 6. History of allergy to study medication 7. Lactating and pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Hamilton anxiety rating scale (HAMA) score 2. Change in somatic symptom scale (SSS8) score 3. Change in plasma BDNF levelTimepoint: At the end of 4 and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment emergent adverse eventsTimepoint: at the end of 4 week and 8 week | — |
Countries
India
Contacts
All India Institute of Medical Sciences, Nagpur