Actively Recruiting
Study of Dapagliflozin Added to Fluoxetine for Treating Depression in Adults A Phase 1 and 2 Randomized, Double-Blind Trial
Led by Tanta University · Updated on 2025-11-25
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Major depressive disorder MDD is a leading cause of disability and suicide worldwide. Despite advances in mental health, many patients do not respond well to current treatments, and a large portion suffer from treatment-resistant depression. Researchers are studying the use of dapagliflozin, a drug originally for diabetes, as a potential antidepressant alongside fluoxetine for MDD treatment. Participants are randomly assigned to one of two groups for 3 months. One group receives fluoxetine 20 mg plus a placebo daily, while the other receives fluoxetine 20 mg plus dapagliflozin 10 mg daily. This double-blind study aims to compare these treatments to evaluate their effects on depression. During the study, participants will be regularly assessed using the 17-item Hamilton Depression Rating Scale HDRS to measure changes in depression severity over 3 months. Quality of life changes will also be evaluated. Safety and treatment adherence will be monitored throughout the trial, which is sponsored by Tanta University.
CONDITIONS
Brief Title
Dapagliflozin in Depression
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