Dapagliflozin in Depression

Sponsor
Tanta University
Study ID
NCT07239011
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Fluoxetine — DRUG
    Fluoxetine is an antidepressant medication of the selective serotonin reuptake inhibitor class used for the treatment of major depressive disorder, anxiety, obsessive-compulsive disorder, panic disorder, premenstrual dysphoric disorder, and bulimia nervosa.
  • Dapagliflozin — DRUG
    Dapagliflozin is a medication used to treat type 2 diabetes. It is also used to treat adults with heart failure and chronic kidney disease. It reversibly inhibits sodium-glucose co-transporter 2 (SGLT-2) in the renal proximal convoluted tubule to reduce glucose reabsorption and increase urinary glucose excretion.

Study Details

Major depressive disorder (MDD) is currently one of the leading causes of disability and suicidal death worldwide, and despite extensive research and massive improvements in mental health, the nature of MDD remains ambiguous. Moreover, about two-thirds of MDD patients fail to optimally respond to currently available standard therapies, and many of them suffer from treatment-resistant depression

Key Dates

Start date
Nov 1, 2025
Status verified
Nov 2025
Primary completion
Nov 20, 2026
Completion
Dec 20, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    Control group (n =30) who will receive fluoxetine (20 mg) and placebo once daily for 3 months
  • Active Comparator: Dapagliflozin group
    Dapagliflozin group (n=30) who will receive fluoxetine (20 mg) once daily plus dapagliflozin 10 mg once daily for 3 months

Primary Outcome Measure

The primary outcome measure was the 17-item HDRS. [ Time Frame: 3 months ]

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