Empagliflozin Adjunctive Therapy in Bipolar Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empagliflozin (EMPA).
- Who it may be relevant to
- Registry conditions: Bipolar Disorder, Bipolar Depression, Insulin Resistance. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Empagliflozin as an Adjunctive Strategy for Treating Bipolar Depression in Patients With Insulin Resistance: A Proof-of-Concept Study (EMPA-BD)
Overview
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.
Interventions
- Drug Empagliflozin (EMPA)
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.
Primary outcome measures
- Change in depressive symptom severity (MADRS total score) [Time frame: Baseline and 12 weeks after treatment initiation]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Institute of Psychiatry, University of São Paulo Medical School (IPq-FMUSP) — São Paulo
Identifiers
NCT: NCT07472920 · 86886125