DepressionPhase 2NCT07007221
Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV
A Phase 2 study testing Metformin, Fluoxetine and Metformin+Fluoxetine in people with Depression and Hiv, run by University of Minnesota.
Trial summary
Depression in HIV occurs commonly and causes poor HIV outcomes with public health implications. Depression prevalence in HIV-infected persons is estimated at 26% compared to 5% in the general population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Hiv
- What is being tested?
- Metformin, Fluoxetine and Metformin+Fluoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Dec 2030
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Provision of Informed Consent
- Willingness to comply with all screening and study procedures
- Primary Residence \<50 km from clinic
Who cannot join
- 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
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- 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)
About this study
Depression in HIV occurs commonly and causes poor HIV outcomes with public health implications.
Depression prevalence in HIV-infected persons is estimated at 26% compared to 5% in the general population. Adherence to antiretroviral medication is a life-saving treatment in HIV, but depression can reduce engagement in care and adherence to medication. Depression is also associated with poorer levels of viral suppression and even mortality. Overall, those with depression and HIV are less likely to return to health and remain more likely to transmit the virus. therefore, treatment of HIV is essential to prevention; lower engagement in and adherence to HIV treatment due to depression puts others at risk. This is a 3 part trial, an initial pilot, a placebo controlled pilot, and a full trial.
Read more
Part 1. Dose response, Tolerability/Acceptability of Metformin for Depression in people with HIV: To do Initial assessment of metformin for depression in people with HIV we will perform a randomized, double blind, 2-arm, 12 week randomized controlled trial to assess feasibility and acceptability of metformin for depression. We will test two doses of metformin 1000 mg daily versus 1500 mg daily.
Part 2. Preliminary Efficacy Trial of Metformin for Depression in People with HIV: This will be a two-arm, double-blind trial of metformin versus placebo in people with HIV and depression. We will randomize individuals 1:1 to metformin or placebo. Will then collect blood and rectal swabs for preliminary assessments of the mechanism of action for metformin in people with HIV and depression.
Part 3. Full efficacy factorial trial of metformin for depression and comparison/interaction with fluoxetine in people living with HIV: To assess metformin and fluoxetine as efficacious treatments for depression in people with HIV, we will conduct a 4-arm, 12-week, mechanistic, double-blinded, randomized controlled treatment trial (RCT) with an assessment of inflammation and the gut microbiome. Participants (n=400) will be HIV- positive patients on ART with comorbid depression receiving care at one of two Ugandan clinics. In addition, we will use the NIMH Research Domain Criteria (RDoC) of Acute Threat and loss under Negative Valence using biomarkers and self-reported tools.
- Conditions
- Depression, Hiv
- Being tested
- Metformin, Placebo, Fluoxetine, Metformin+Fluoxetine, double placebo
- Medical subject headings
- Depression, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
12 weeks of Metformin 1000mg
MetforminDrug
12 weeks of Metformin 1500mg
MetforminDrug
8 weeks of Metformin
PlaceboOther
8 weeks placebo drug
MetforminDrug
12 weeks of Metformin
FluoxetineDrug
12 weeks of Fluoxetine
Metformin+FluoxetineDrug
12 weeks of Metformin+Fluoxetine
double placeboOther
12 weeks of double placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1, group 1 | Experimental | HIV patients with depression randomized to metformin dose 1000mg Receives: Drug: Metformin |
| Part 1, group 2 | Experimental | HIV patients with depression randomized to metformin dose 1500mg Receives: Drug: Metformin |
| Part 2, group1 | Experimental | HIV patients with depression randomized to metformin Receives: Drug: Metformin |
| Part 2, group 2 | Placebo comparator | HIV patients with depression randomized to placebo Receives: Other: Placebo |
| Part 3, group 1 | Experimental | HIV patients with depression randomized to Metformin Receives: Drug: Metformin |
| Part 3, group 2 | Experimental | HIV patients with depression randomized to fluoxetine Receives: Drug: Fluoxetine |
| Part 3, group 3 | Experimental | HIV patients with depression randomized to metformin + fluoxetine Receives: Drug: Metformin+Fluoxetine |
| Part 3, group 4 | Experimental | HIV patients with depression randomized to double placebo Receives: Other: double placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS Score
A score indicating depression severity, ranging from 0-60 with a higher score indicating more severe depression
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Why it stopped: Study was not initiated because funding was not received.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 3 part trial, parts 1 and 2 have 2 arms each, part 3 has 4 arms
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Lofgren, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007221
- Sponsor's protocol ID
- IDIM-2024-31723
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV
- ClinicalTrials.gov ID
- NCT07007221
- Acronym / sponsor ID
- IDIM-2024-31723
- Conditions
- Depression, Hiv
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not initiated because funding was not received.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Depression in HIV occurs commonly and causes poor HIV outcomes with public health implications.
Depression prevalence in HIV-infected persons is estimated at 26% compared to 5% in the general population. Adherence to antiretroviral medication is a life-saving treatment in HIV, but depression can reduce engagement in care and adherence to medication. Depression is also associated with poorer levels of viral suppression and even mortality. Overall, those with depression and HIV are less likely to return to health and remain more likely to transmit the virus. therefore, treatment of HIV is essential to prevention; lower engagement in and adherence to HIV treatment due to depression puts others at risk. This is a 3 part trial, an initial pilot, a placebo controlled pilot, and a full trial.
Part 1. Dose response, Tolerability/Acceptability of Metformin for Depression in people with HIV: To do Initial assessment of metformin for depression in people with HIV we will perform a randomized, double blind, 2-arm, 12 week randomized controlled trial to assess feasibility and acceptability of metformin for depression. We will test two doses of metformin 1000 mg daily versus 1500 mg daily.
Part 2. Preliminary Efficacy Trial of Metformin for Depression in People with HIV: This will be a two-arm, double-blind trial of metformin versus placebo in people with HIV and depression. We will randomize individuals 1:1 to metformin or placebo. Will then collect blood and rectal swabs for preliminary assessments of the mechanism of action for metformin in people with HIV and depression.
Part 3. Full efficacy factorial trial of metformin for depression and comparison/interaction with fluoxetine in people living with HIV: To assess metformin and fluoxetine as efficacious treatments for depression in people with HIV, we will conduct a 4-arm, 12-week, mechanistic, double-blinded, randomized controlled treatment trial (RCT) with an assessment of inflammation and the gut microbiome. Participants (n=400) will be HIV- positive patients on ART with comorbid depression receiving care at one of two Ugandan clinics. In addition, we will use the NIMH Research Domain Criteria (RDoC) of Acute Threat and loss under Negative Valence using biomarkers and self-reported tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
- Model description
- This is a 3 part trial, parts 1 and 2 have 2 arms each, part 3 has 4 arms
| Arm | Type | Receives |
|---|---|---|
| Part 1, group 1 | Experimental | Drug: MetforminHIV patients with depression randomized to metformin dose 1000mg |
| Part 1, group 2 | Experimental | Drug: MetforminHIV patients with depression randomized to metformin dose 1500mg |
| Part 2, group1 | Experimental | Drug: MetforminHIV patients with depression randomized to metformin |
| Part 2, group 2 | Placebo comparator | Other: PlaceboHIV patients with depression randomized to placebo |
| Part 3, group 1 | Experimental | Drug: MetforminHIV patients with depression randomized to Metformin |
| Part 3, group 2 | Experimental | Drug: FluoxetineHIV patients with depression randomized to fluoxetine |
| Part 3, group 3 | Experimental | Drug: Metformin+FluoxetineHIV patients with depression randomized to metformin + fluoxetine |
| Part 3, group 4 | Experimental | Other: double placeboHIV patients with depression randomized to double placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-65 years old
- HIV positive
- On HIV antiretroviral therapy for \> 6 months
- Undetectable HIV RNA
- Outpatient
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin12 weeks of Metformin 1000mg | Drug | Part 1, group 1 |
| Metformin12 weeks of Metformin 1500mg | Drug | Part 1, group 2 |
| Metformin8 weeks of Metformin | Drug | Part 2, group1 |
| Placebo8 weeks placebo drug | Other | Part 2, group 2 |
| Metformin12 weeks of Metformin | Drug | Part 3, group 1 |
| Fluoxetine12 weeks of Fluoxetine | Drug | Part 3, group 2 |
| Metformin+Fluoxetine12 weeks of Metformin+Fluoxetine | Drug | Part 3, group 3 |
| double placebo12 weeks of double placebo | Other | Part 3, group 4 |
Primary outcome
MADRS Score
Time frame: 8 weeks
A score indicating depression severity, ranging from 0-60 with a higher score indicating more severe depression
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Lofgren, MD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin, Fluoxetine and Metformin+Fluoxetine in people with Depression and Hiv, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.