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August 1, 2026Indian Journal of PsychiatryOpen Access

Effectiveness of fluoxetine and mindfulness therapy in improving depression in people with Type 2 Diabetes Mellitus in Primary Care Settings (DIAMAND)—A single-blind, parallel-group, randomized controlled trial from Bengaluru

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Key result

Fluoxetine and mindfulness therapy show no benefit over usual care for mild depression in T2DM.

  • Effect size 0.48 for Mindfulness, 0.45 for Fluoxetine, 0.31 for combination
  • n=200

Why the study?

Evidence comparing pharmacological and psychological interventions for mild depression in type 2 diabetes mellitus within primary care settings remains limited.

Does fluoxetine, mindfulness therapy, or their combination improve depressive symptoms in individuals with Type 2 Diabetes Mellitus and mild depression compared to treatment as usual?

Population

200 individuals with T2DM and mild depression from Bengaluru

Comparison

Fluoxetine vs mindfulness therapy vs combination treatment vs treatment as usual

Design

Single-blind parallel-group randomized controlled trial

Follow-up

4 months

Authors

DRDhanya RaveendranathanNorthern HealthJRJohnson-Pradeep RubenBehavioral Tech Research, Inc.BGB. Ramakrishna GoudSt.John's Medical College Hospital

Discussion

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Overview

In patients with T2DM and mild depression, neither fluoxetine, mindfulness therapy, nor their combination demonstrated superiority over treatment as usual in reducing depressive symptoms over 4 months.

Study Design

Type

RCT (n=200)

Blinding

single-blind

Randomization

parallel-group

Multicenter

Yes

Structured PICO

Does fluoxetine, mindfulness therapy, or their combination improve depressive symptoms in individuals with Type 2 Diabetes Mellitus and mild depression compared to treatment as usual?

P
Population
200 individuals with Type 2 Diabetes Mellitus and mild depression, randomized to fluoxetine, mindfulness therapy, combination treatment, or treatment as usual, and followed for 4 months.
I
Intervention
Fluoxetine, Mindfulness therapy, or combination of Fluoxetine and Mindfulness therapy
C
Comparator
Treatment as usual (TAU)
O
Outcome
Depression severity over 4 monthspatient reported

Main Result

Effect estimate: Effect size 0.48 for Mindfulness, 0.45 for Fluoxetine, 0.31 for combination

In patients with T2DM and mild depression, neither fluoxetine, mindfulness therapy, nor their combination demonstrated superiority over treatment as usual in reducing depressive symptoms over 4 months.

Limitations

  • Potentially underpowered
  • Short follow-up duration
  • short follow-up
  • potentially underpowered

Cite This Study

Raveendranathan et al. (2026) conducted an RCT in Type 2 Diabetes Mellitus and mild depression (n=200). Fluoxetine, Mindfulness therapy, or combination Fluoxetine + Mindfulness vs. Treatment as usual (TAU) was evaluated on Reduction in depressive symptoms (Effect size 0.48 for Mindfulness, 0.45 for Fluoxetine, 0.31 for combination). Fluoxetine, mindfulness therapy, and their combination did not demonstrate superiority over treatment as usual in reducing depressive symptoms among patients with T2DM and mild depression.

synapsesocial.com/papers/6aa95698a35b18e46c04ffc7https://doi.org/10.4103/indianjpsychiatry_803_24
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Development of a Rating Scale for Primary Depressive Illness1967 · 8,511 citations
  2. 2Quality of life and metabolic status in mildly depressed patients with type 2 diabetes treated with paroxetine: A double-blind randomised placebo controlled 6-month trial2007 · 81 citations
  3. 3Development of the World Health Organization WHOQOL-BREF Quality of Life Assessment1998 · 8,006 citations
  4. 4Emerging global interest: Unraveling the link between diabetes mellitus and depression2024 · 12 citations
  5. 5The Association Between Selective Serotonin Reuptake Inhibitors and Glycemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials2019 · 33 citations