Dapagliflozin with fluoxetine for major depressive disorder
Official title: Dapagliflozin, an SGLT2 Inhibitor, From Oral Hypoglycemic Agent to Antidepressant Drug
Run by Tanta University · NCT07239011 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Damietta, New Damietta) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | November 20, 2026 |
| Study ends | December 20, 2026 |
| Registry record updated | November 25, 2025 |
| Trial ID | NCT07239011 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Mostafa Bahaa
Damietta, New Damietta, Egypt Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Smartphone-supported single-session psychotherapy for postpartum depression
A single online therapy session plus four weeks of app-based support is being tested to see if it reduces depressive symptoms in postpartum women compared with a waitlist.
-
Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges
This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.
-
Tele-based wellbeing centres for women's mental health in Bangladesh
A randomized trial tests whether tele-counselling for depression and anxiety in Bangladeshi women is as effective as in-person counselling.
-
Remote monitoring for adults with depression using ThIA Suivi
This study tests whether adding the ThIA Suivi remote monitoring tool to usual psychiatric care helps adults with depression feel more improved after 3 months compared with standard care alone.
-
HBOT to see if it helps cognition and well‑being in first responders with prior brain injury
This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.
-
Focused ultrasound for mood and anxiety disorders
This study tests whether repeated low-intensity focused ultrasound using the ATTN201 device can help people with subsyndromal to moderate depression, anxiety, or OCD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.