Empagliflozin added to treatment for bipolar depression in people with insulin resistance
Tests empagliflozin as an add-on in adults with bipolar depression and insulin resistance.
Plain-language title generated from the registry record
Registry title: Empagliflozin Adjunctive Therapy in Bipolar Depression
Key facts
- Where
- São Paulo, BrazilSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07472920, who can take part
Where in Brazil
- Institute of Psychiatry, University of São Paulo Medical School (IPq-FMUSP)São Paulo, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Sao Paulo
- Trial code
- NCT07472920
- Record updated
- 16 March 2026
- Original description
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 full original descriptionShow less
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.
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.
Inclusion: 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.
Exclusion: History of hypersensitivity to empagliflozin or any SGLT2 inhibitor; Known pancreatic disease (pancreatitis or pancreatic surgery); Recurrent genital fungal infections; Type 1 or type 2 diabetes mellitus or HbA1c ≥ 6.5% at screening; Chronic kidney disease (eGFR < 30 mL/min/1.73m²); Pregnant or breastfeeding; Alcohol abuse or dependence within the past 12 months; YMRS score ≥ 12 (presence of manic or hypomanic symptoms).