Empagliflozin Adjunctive Therapy in Bipolar Depression

Sponsor
University of Sao Paulo
Study ID
NCT07472920
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin (EMPA) — DRUG
    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 Details

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.

Key Dates

Start date
Mar 9, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin Adjunctive Therapy in Bipolar Depression
    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.

Primary Outcome Measure

Change in depressive symptom severity (MADRS total score) [ Time Frame: Baseline and 12 weeks after treatment initiation ]

Central Contacts

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