Health Condition 1: F320- Major depressive disorder, singleepisode, mild
Conditions
Interventions
Intervention1: fluoxetine: tab fluoxetine 20-60 mg /day
oral
Once Daily
Duration: 16 weeks
Intervention2: mindfulness: psychotherapeutic intervention
Control Intervention1: treatment as usual: treatm
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: • T2DM with Major depression • Both genders between the age range of 20 to 60 yrs. • On stable dosages of Oral Hypoglycaemic agents (OHA) for past three months • HbA1C should be above 7.5 and above • Diagnosed with Major Depression using MINI with a score of 8 and above on HAM-D 17 item version
Exclusion criteria
Exclusion criteria: 1. Antidepressant use for any indications in the last 3 months 2. Current insulin therapy 3. Major complications of T2DM like retinopathy, nephropathy 4. Uncontrolled HTN 5. Major psychiatric disorders (such as Schizophrenia, BPAD) or substance abuse disorders except Tobacco. 6. Pregnancy 7. Suicidal ideation or gestures or psychotic symptoms or severe agitation. 8. Head injury, Cerebrovascular disorders, dementia, seizure disorders, Mental retardation 9. Recent Myocardial Infarction in past 3 months 10. Allergy to antidepressant
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Quality of life, Mindfulness,Timepoint: 0,2,4,6,8,12,16 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Depression, diabetes self management, treatment adherance, mindfulness, quality of lifeTimepoint: 0, 2,4,6,8,12,16 weeks | — |
Countries
India
Contacts
Public ContactMina Chandra
Ram Manohar Lohia Hospital
Outcome results
None listed