Empagliflozin as an Adjunctive Strategy for Treating Bipolar Depression in Patients With Insulin Resistance: A Proof-of-Concept Study (EMPA-BD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in depressive symptom severity (MADRS total score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study; no masking will be used.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Empagliflozin (EMPA) (Drug)
结局指标
主要结局
Change in depressive symptom severity (MADRS total score)
时间窗: Baseline and 12 weeks after treatment initiation
The Montgomery-Åsberg Depression Rating Scale (MADRS) will be used to assess depressive symptom severity. The scale includes 10 clinician-rated items, with higher scores indicating more severe depression. The primary outcome is the change in total MADRS score from baseline to week 12 of treatment with empagliflozin.
次要结局
- Change in insulin resistance (HOMA-IR)(Baseline and 12 weeks after treatment initiation)
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(Throughout the 12-week study period)
研究者
Beny Lafer
Associated professor
University of Sao Paulo