Bipolar DisorderEMPA-BDNCT07472920
Empagliflozin Adjunctive Therapy in Bipolar Depression
A study testing Empagliflozin (EMPA) in people with Bipolar Disorder and Bipolar Depression, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Bipolar disorder is a long-term mental health condition that causes mood changes, with depressive episodes being the most frequent and disabling. Many people do not fully recover with current treatments, showing the need for new therapeutic options. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression, Insulin Resistance
- What is being tested?
- Empagliflozin (EMPA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Mar 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18 to 65 years.
- Diagnosis of Bipolar Disorder type I or II according to DSM-5 criteria, confirmed by the MINI International Neuropsychiatric Interview.
- Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 15 at screening.
- Currently receiving stable pharmacological treatment for bipolar disorder, with no medication changes (addition or withdrawal) in the past 4 weeks.
- Ability to provide informed consent.
- Insulin resistance, defined as HOMA-IR ≥ 1.8.
Who cannot join
- History of hypersensitivity to empagliflozin or any SGLT2 inhibitor.
- Type 1 or type 2 diabetes mellitus or HbA1c ≥ 6.5% at screening.
- Known pancreatic disease (pancreatitis or pancreatic surgery).
- Chronic kidney disease (eGFR < 30 mL/min/1.73m²).
- Recurrent genital fungal infections.
- Pregnant or breastfeeding.
- Alcohol abuse or dependence within the past 12 months.
- YMRS score ≥ 12 (presence of manic or hypomanic symptoms).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Institute of Psychiatry, University of São Paulo Medical School (IPq-FMUSP)
São Paulo, São Paulo, 05403-903
Eliana Landivar, +55 11 2661 7890, eliana.landivar@hc.fm.usp.br
Eliana Landivar, MD
About this study
Official title: Empagliflozin as an Adjunctive Strategy for Treating Bipolar Depression in Patients With Insulin Resistance: A Proof-of-Concept Study (EMPA-BD)
Bipolar disorder is a long-term mental health condition that causes mood changes, with depressive episodes being the most frequent and disabling. Many people do not fully recover with current treatments, showing the need for new therapeutic options.
Recent research shows that insulin resistance (IR), a condition in which the body does not respond well to insulin, is common in people with bipolar disorder. It is linked to more severe mood symptoms, poorer treatment response, and higher risk of heart disease. IR may raise inflammation and affect how the brain uses energy, which can influence mood regulation.
Read more
Empagliflozin is a medicine approved for type 2 diabetes. In addition to its metabolic and heart benefits, studies suggest that it may also protect the brain and reduce inflammation, possibly helping to improve mood.
This open-label, proof-of-concept clinical trial will test how well empagliflozin works and how safe it is as an add-on treatment for people with bipolar depression and insulin resistance. A total of 20 adults with bipolar disorder type I or II, currently in a depressive episode, will take part in the study over a 12-week period.
The main goal is to see whether empagliflozin can lower depressive symptoms, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). Other measures include changes in insulin resistance and incidence of adverse events.
The study aims to explore whether improving insulin resistance can help both mood and metabolic health in people with bipolar disorder, guiding future clinical research.
Read the detailed description
This study is an open-label, single-arm, proof-of-concept clinical trial evaluating empagliflozin as an adjunctive treatment for bipolar depression in individuals with insulin resistance. Adults with bipolar disorder type I or II who are currently experiencing a depressive episode and receiving stable pharmacological treatment will receive empagliflozin for 12 weeks.
Depressive symptom severity will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). Insulin resistance will be evaluated using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), and safety will be monitored through assessment of treatment-emergent adverse events throughout the study period.
- Conditions
- Bipolar Disorder, Bipolar Depression, Insulin Resistance
- Being tested
- Empagliflozin (EMPA)
- Keywords
- Bipolar Disorder, Bipolar Depression, Insulin Resistance, Empagliflozin, SGLT2 Inhibitors, Metabolic Psychiatry
- Medical subject headings
- Bipolar Disorder, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin (EMPA)Drug
Also called Jardiance
Empagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor administered orally once daily. Participants will start with 10 mg/day for the first 2 weeks, followed by 25 mg/day for the next 10 weeks, completing a 12-week intervention period. The drug will be used as an adjunctive treatment to standard psychiatric therapy in adults with bipolar depression and insulin resistance. Safety and tolerability will be monitored throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin Adjunctive Therapy in Bipolar Depression | Experimental | Participants will receive empagliflozin orally once daily as an adjunct to their usual psychiatric treatment. The dose will start at 10 mg/day for the first 2 weeks and increase to 25 mg/day for the following 10 weeks, totaling a 12-week intervention period. The study will evaluate changes in depressive symptoms, insulin resistance, and metabolic parameters in adults with bipolar depression and insulin resistance. All participants will continue their standard psychiatric medications under medical supervision throughout the study. Receives: Drug: Empagliflozin (EMPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptom severity (MADRS total score)
The Montgomery-Åsberg Depression Rating Scale (MADRS) will be used to assess depressive symptom severity. The scale includes 10 clinician-rated items, with higher scores indicating more severe depression. The primary outcome is the change in total MADRS score from baseline to week 12 of treatment with empagliflozin.
Measured: Baseline and 12 weeks after treatment initiation
Secondary outcomes (2)
Change in insulin resistance (HOMA-IR)
Insulin resistance will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and insulin levels. The outcome will be the change in HOMA-IR from baseline to week 12.
Measured: Baseline and 12 weeks after treatment initiation
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Adverse events will be recorded throughout the 12-week study period. Safety will be assessed through adverse event monitoring, clinical evaluation, and laboratory tests (including renal function and electrolytes).
Measured: Throughout the 12-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start9 Mar 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, single-arm, proof-of-concept trial evaluating the effects of empagliflozin as an adjunctive treatment for bipolar depression.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beny Lafer, University of Sao Paulo
- Investigators
- Beny Lafer, MD, PhD, Principal investigator, Institute of Psychiatry, University of São Paulo Medical School (IPq-FMUSP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472920
- Sponsor's protocol ID
- 86886125
- Acronym
- EMPA-BD
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared because this is a small, proof-of-concept, single-site study. The dataset includes sensitive clinical information that could potentially identify participants. Only aggregated and anonymized results will be shared in future scientific publications or presentations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empagliflozin as an Adjunctive Strategy for Treating Bipolar Depression in Patients With Insulin Resistance: A Proof-of-Concept Study (EMPA-BD)
- ClinicalTrials.gov ID
- NCT07472920
- Acronym / sponsor ID
- EMPA-BD / 86886125
- Conditions
- Bipolar Disorder, Bipolar Depression, Insulin Resistance
- Keywords
- Bipolar Disorder, Bipolar Depression, Insulin Resistance, Empagliflozin, SGLT2 Inhibitors, Metabolic Psychiatry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Mar 2026 (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.
Bipolar disorder is a long-term mental health condition that causes mood changes, with depressive episodes being the most frequent and disabling. Many people do not fully recover with current treatments, showing the need for new therapeutic options.
Recent research shows that insulin resistance (IR), a condition in which the body does not respond well to insulin, is common in people with bipolar disorder. It is linked to more severe mood symptoms, poorer treatment response, and higher risk of heart disease. IR may raise inflammation and affect how the brain uses energy, which can influence mood regulation.
Empagliflozin is a medicine approved for type 2 diabetes. In addition to its metabolic and heart benefits, studies suggest that it may also protect the brain and reduce inflammation, possibly helping to improve mood.
This open-label, proof-of-concept clinical trial will test how well empagliflozin works and how safe it is as an add-on treatment for people with bipolar depression and insulin resistance. A total of 20 adults with bipolar disorder type I or II, currently in a depressive episode, will take part in the study over a 12-week period.
The main goal is to see whether empagliflozin can lower depressive symptoms, measured with the Montgomery-Åsberg Depression Rating Scale (MADRS). Other measures include changes in insulin resistance and incidence of adverse events.
The study aims to explore whether improving insulin resistance can help both mood and metabolic health in people with bipolar disorder, guiding future clinical research.
Detailed description
This study is an open-label, single-arm, proof-of-concept clinical trial evaluating empagliflozin as an adjunctive treatment for bipolar depression in individuals with insulin resistance. Adults with bipolar disorder type I or II who are currently experiencing a depressive episode and receiving stable pharmacological treatment will receive empagliflozin for 12 weeks.
Depressive symptom severity will be assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS). Insulin resistance will be evaluated using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), and safety will be monitored through assessment of treatment-emergent adverse events throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single-arm, proof-of-concept trial evaluating the effects of empagliflozin as an adjunctive treatment for bipolar depression.
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin Adjunctive Therapy in Bipolar Depression | Experimental | Drug: Empagliflozin (EMPA)Participants will receive empagliflozin orally once daily as an adjunct to their usual psychiatric treatment. The dose will start at 10 mg/day for the first 2 weeks and increase to 25 mg/day for the following 10 weeks, totaling a 12-week intervention period. The study will evaluate changes in depressive symptoms, insulin resistance, and metabolic parameters in adults with bipolar depression and insulin resistance. All participants will continue their standard psychiatric medications under medical supervision throughout the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 65 years.
- Diagnosis of Bipolar Disorder type I or II according to DSM-5 criteria, confirmed by the MINI International Neuropsychiatric Interview.
- Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 15 at screening.
- Currently receiving stable pharmacological treatment for bipolar disorder, with no medication changes (addition or withdrawal) in the past 4 weeks.
- Ability to provide informed consent.
Key exclusion criteria (8 listed)
- History of hypersensitivity to empagliflozin or any SGLT2 inhibitor.
- Type 1 or type 2 diabetes mellitus or HbA1c ≥ 6.5% at screening.
- Known pancreatic disease (pancreatitis or pancreatic surgery).
- Chronic kidney disease (eGFR < 30 mL/min/1.73m²).
- Recurrent genital fungal infections.
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 |
|---|---|---|
| Empagliflozin (EMPA)Also: JardianceEmpagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor administered orally once daily. Participants will start with 10 mg/day for the first 2 weeks, followed by 25 mg/day for the next 10 weeks, completing a 12-week intervention period. The drug will be used as an adjunctive treatment to standard psychiatric therapy in adults with bipolar depression and insulin resistance. Safety and tolerability will be monitored throughout the study. | Drug | Empagliflozin Adjunctive Therapy in Bipolar Depression |
Primary outcome
Change in depressive symptom severity (MADRS total score)
Time frame: Baseline and 12 weeks after treatment initiation
The Montgomery-Åsberg Depression Rating Scale (MADRS) will be used to assess depressive symptom severity. The scale includes 10 clinician-rated items, with higher scores indicating more severe depression. The primary outcome is the change in total MADRS score from baseline to week 12 of treatment with empagliflozin.
2 secondary outcomes
Change in insulin resistance (HOMA-IR)
Time frame: Baseline and 12 weeks after treatment initiation
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Throughout the 12-week study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared because this is a small, proof-of-concept, single-site study. The dataset includes sensitive clinical information that could potentially identify participants. Only aggregated and anonymized results will be shared in future scientific publications or presentations.
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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.
Beny Lafer, MD, PhD principal investigator
Institute of Psychiatry, University of São Paulo Medical School (IPq-FMUSP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empagliflozin (EMPA) in people with Bipolar Disorder and Bipolar Depression, run by University of Sao Paulo at 1 site in Brazil.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliana Landivar, MD (+55 11 2661 7890, eliana.landivar@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptom severity (MADRS total score) (time frame: Baseline and 12 weeks after treatment initiation). 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 16 Mar 2026.