Last updated 3 days ago

Empagliflozin Adjunctive Therapy in Bipolar Depression

20 patients around the world
Available in Brazil
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.
University of Sao Paulo
1Research sites
20Patients around the world

This study is for people with

Bipolar disorder
Depression
Bipolar major depression

Requirements for the patient

To 65 Years
All Gender

Medical requirements

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.
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).

Sites

Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Rua Dr. Ovídio Pires de Campos 785 - Estado de São Paulo 05403-000
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