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Could a diabetes pill lift depression? new trial aims to find out

NCT ID NCT07239011

Symptom relief Sponsor: Tanta University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether dapagliflozin, a drug normally used for diabetes, can help reduce depression symptoms when added to standard antidepressant treatment. Sixty adults with moderate to severe depression will receive either dapagliflozin plus fluoxetine or fluoxetine alone. The goal is to see if the combination leads to greater improvement in mood and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dapagliflozin
What this could lead to
If it works, this could point toward a new, repurposed treatment option for depression, especially for people who don't respond well to current antidepressants.
What could go wrong
This is an early, small Phase 1/2 trial with only 60 participants, so results may not apply broadly. Dapagliflozin is not yet proven for depression and may cause side effects like dehydration or urinary infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mostafa Bahaa

    RECRUITING

    Damietta, New Damietta, 34518, Egypt

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