NCT07472920Not yet recruiting
Empagliflozin Adjunctive Therapy in Bipolar Depression
Empagliflozin as an Adjunctive Strategy for Treating Bipolar Depression in Patients With Insulin Resistance: A Proof-of-Concept Study (EMPA-BD)
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 5 Mar 2026
- Start date
- 9 Mar 2026
- Primary completion date
- Sept 2026
- Lead sponsor
- University of Sao Paulo
- Diseases
- Bipolar disorder
- NCT number
- NCT07472920
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 9 Mar 2026 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of hypersensitivity to empagliflozin or any SGLT2 inhibitor.
- Known pancreatic disease (pancreatitis or pancreatic surgery).
- Recurrent genital fungal infections.
Lab values
- Type 1 or type 2 diabetes mellitus or HbA1c ≥ 6.5% at screening.
- Chronic kidney disease (eGFR \< 30 mL/min/1.73m²).
Other
- Pregnant or breastfeeding.
- Alcohol abuse or dependence within the past 12 months.
- YMRS score ≥ 12 (presence of manic or hypomanic symptoms).
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Psychiatry, University of São Paulo Medical School (IPq-FMUSP) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.