Fluoxetine vs mindfulness for depression in diabetes.

Phase 4

• Conditions: Health Condition 1: F320- Major depressive disorder, singleepisode, mild

• Registration Number: CTRI/2019/01/017239
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression, diabetes self management, treatment adherance, mindfulness, quality of lifeTimepoint: 0, 2,4,6,8,12,16 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life, Mindfulness,Timepoint: 0,2,4,6,8,12,16 weeks