Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07472920
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged 18 to 65 years.
2. Diagnosis of Bipolar Disorder type I or II according to DSM-5 criteria, confirmed by the MINI International Neuropsychiatric Interview.
3. Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥ 15 at screening.
4. Currently receiving stable pharmacological treatment for bipolar disorder, with no medication changes (addition or withdrawal) in the past 4 weeks.
5. Ability to provide informed consent.
6. Insulin resistance, defined as HOMA-IR ≥ 1.8.
Exclusion Criteria:
1. History of hypersensitivity to empagliflozin or any SGLT2 inhibitor.
2. Type 1 or type 2 diabetes mellitus or HbA1c ≥ 6.5% at screening.
3. Known pancreatic disease (pancreatitis or pancreatic surgery).
4. Chronic kidney disease (eGFR \< 30 mL/min/1.73m²).
5. Recurrent genital fungal infections.
6. Pregnant or breastfeeding.
7. Alcohol abuse or dependence within the past 12 months.
8. YMRS score ≥ 12 (presence of manic or hypomanic symptoms).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07472920
Study Brief:
Protocol Section:
NCT07472920