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Could a diabetes pill lift bipolar depression? small study aims to find out

NCT ID NCT07472920

Symptom relief Sponsor: University of Sao Paulo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether empagliflozin, a drug used for diabetes, can help reduce depression in people with bipolar disorder who also have insulin resistance. Twenty adults with bipolar depression will take the drug for 12 weeks alongside their usual treatment. The goal is to see if improving insulin resistance can improve mood and guide future research.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

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 65 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: 1. Adults aged 18 to 65 years. 2. Diagnosis of Bipolar Disorder type I or II according to DSM-5 criteria, confirmed by the MINI International Neuropsychiatric Interview. 3. Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 15 at screening. 4. Currently receiving stable pharmacological treatment for bipolar disorder, with no medication changes (addition or withdrawal) in the past 4 weeks. 5. Ability to provide informed consent. 6. Insulin resistance, defined as HOMA-IR ≥ 1.8. Exclusion Criteria: 1. History of hypersensitivity to empagliflozin or any SGLT2 inhibitor. 2. Type 1 or type 2 diabetes mellitus or HbA1c ≥ 6.5% at screening. 3. Known pancreatic disease (pancreatitis or pancreatic surgery). 4. Chronic kidney disease (eGFR \< 30 mL/min/1.73m²). 5. Recurrent genital fungal infections. 6. Pregnant or breastfeeding. 7. Alcohol abuse or dependence within the past 12 months. 8. YMRS score ≥ 12 (presence of manic or hypomanic symptoms).

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Conditions

The condition(s) this trial relates to.

bipolar depression bipolar disorder bipolar I disorder bipolar II disorder Insulin Resistance

As listed by the trial registrant

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

Bipolar depression Bipolar disorder Insulin resistance

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

  • Institute of Psychiatry, University of São Paulo Medical School (IPq-FMUSP)

    São Paulo, São Paulo, 05403-903, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.