Dapagliflozin with fluoxetine for major depressive disorder
Dapagliflozin, an SGLT2 Inhibitor, From Oral Hypoglycemic Agent to Antidepressant Drug
This will try adding dapagliflozin to fluoxetine to see if it helps adults with moderate-to-severe major depressive disorder.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Damietta, New Damietta) |
| Trial ID | NCT07239011 on ClinicalTrials.gov |
What this trial studies
This is a phase 1/2 interventional trial conducted at a single center enrolling adults with major depressive disorder of at least two months' duration and a Hamilton rating score over 18. Participants receive fluoxetine and dapagliflozin with regular monitoring for changes in depressive symptoms and for safety and tolerability. The trial excludes people with bipolar disorder, active substance dependence, diabetes, severe kidney disease, recent ECT, or pregnancy/lactation. Outcomes will focus on symptom change (Hamilton rating) and adverse events to provide preliminary efficacy and safety data.
Who should consider this trial
Good fit: Adults aged 18 or older with major depressive disorder lasting at least two months and a Hamilton rating score >18 who are not pregnant, not diabetic, and without bipolar disorder, substance dependence, severe kidney disease, or contraindications to the study drugs.
Not a fit: People with bipolar I/II, active substance dependence or abuse, diabetes, severe renal impairment, pregnancy or lactation, or primary personality or eating disorders are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding dapagliflozin could improve depressive symptoms and offer a new treatment option for patients who do not fully respond to standard antidepressants.
How similar studies have performed: Repurposing SGLT2 inhibitors like dapagliflozin for depression is largely novel with limited clinical data, though some preclinical and mechanistic studies suggest possible neuroprotective or anti-inflammatory effects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Depressed patients for at least 2 months with Hamilton rating score more than 18. Exclusion Criteria: Patients with bipolar I or bipolar II disorder, personality disorders, and eating disorders. Patients with substance dependence or abuse Patients with history of seizures or receiving electroconvulsive therapy (ECT) Patients with inflammatory disorders Patients with allergy or contraindications to the used medications Patients with finally pregnant or lactating females Diabetic patients Sever kidney disorders
Where this trial is running
Damietta, New Damietta
- Mostafa Bahaa — Damietta, New Damietta, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.