CTRI/2019/01/017239Not yet recruitingPhase 4
Managing depression in diabetes: A multi centre randomized controlled effectiveness comparison trial of fluoxetine and mindfulness in primary care settings.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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