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Could a common diabetes drug lift depression in HIV patients?

NCT ID NCT07007221

Symptom relief Sponsor: University of Minnesota 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 1 time

Summary

This study tests whether metformin, a standard diabetes drug, can help treat depression in people living with HIV. Researchers will enroll 600 adults with HIV and depression, giving them metformin, fluoxetine (a standard antidepressant), both, or a placebo for up to 12 weeks. The goal is to see if metformin improves mood and reduces inflammation, potentially offering a new, accessible treatment option.

What this could mean

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

Active substance
Metformin
What this could lead to
If it works, this could offer a new, affordable way to treat depression in people with HIV, improving both mental health and HIV outcomes.
What could go wrong
This is an early phase 2 trial with multiple parts, so results are uncertain. Depression is complex, and metformin may not work for everyone or may cause side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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: * 18-65 years old * HIV positive * On HIV antiretroviral therapy for \> 6 months * Undetectable HIV RNA * Outpatient * Depression by PHQ-9 \>10, confirmed by MADRS score 20+ and MINI interview * Provision of Informed Consent * Willingness to comply with all screening and study procedures * Primary Residence \<50 km from clinic Exclusion Criteria: * Planning to move out of clinic catchment area in the next 3 months * Suicidal (PHQ-9 question 9 score \>2) or MADRS item 10 with score of 4+ * Pregnant or breastfeeding * Treatment with a rifamycin * Current use of any antidepressant, metformin, rifampicin, efavirenz, insulin, or sulfonylurea. * Active illicit drug use * Bipolar or psychotic disorder * Known cirrhosis or heart failure * Glomerular Filtration Rate (GFR) \<45 * Abnormal TSH \>3.5 IU/mL * Previous Enrollment in the trial (Parts 2 and 3)

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Conditions

The condition(s) this trial relates to.

AIDS Depression depressive disorder HIV infectious disease

As listed by the trial registrant

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

Depression HIV

More trials for these conditions

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