None listed
Conditions
Interventions
Drug : This study is a multicenter, randomized, open-label comparative clinical trial designed to evaluate the effects of adjunctive metformin therapy on weight gain and functional brain connectivity
Sponsors
Chung-Ang Univerisity Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. Adults aged 19 years or older and younger than 65 years B. Diagnosed with schizophrenia, bipolar I or II disorder, or schizoaffective disorder according to DSM-5 diagnostic criteria C. Has been taking olanzapine at a stable dose of at least 5 mg/day for a minimum of 4 weeks prior to screening D. Has a body mass index (BMI) = 30 kg/m², or BMI between 27 and 29.9 kg/m² with at least one metabolic comorbidity (e.g., hypertension or hyperlipidemia; diabetes is an exclusion criterion) E. Able to understand the study explanation and voluntarily provide written informed consent F. If female of childbearing potential, agrees to use a reliable method of contraception during the clinical trial and for at least 4 weeks after its completion (e.g., combined hormonal contraceptives, intrauterine device, tubal ligation, partner vasectomy, or dual barrier methods such as male condom with female diaphragm). Use of single hormonal methods, rhythm method, or abstinence is not permitted. Additionally, agrees to perform a monthly urine pregnancy test using a home testing kit during the study period and report the results to the investigator G. Eligible for functional magnetic resonance imaging (fMRI) scanning
Exclusion criteria
Exclusion criteria: A. Diagnosed diabetes mellitus or fasting plasma glucose (FPG) = 126 mg/dL, or HbA1c = 6.5% B. Use of antidiabetic medications or lipid-lowering agents within the past 8 weeks, or triglyceride level > 500 mg/dL C. Moderate to severe liver disease (AST/ALT > 3×ULN, total bilirubin > 2×ULN, or Child-Pugh class B or higher) D. Moderate to severe renal impairment (eGFR 1.4 mg/dL [female] / > 1.5 mg/dL [male]) E. Severe cardiovascular or respiratory disease (e.g., NYHA class III or higher heart failure, myocardial infarction or stroke within the past 6 months, COPD of GOLD stage III or higher) F. History of hypersensitivity or contraindications to olanzapine or metformin G. History of lactic acidosis or severe hypoxia H. Impaired decision-making capacity due to substance abuse, alcohol dependence, or psychotic symptoms I. Recent suicide attempt or high risk of suicide J. Ineligibility for MRI scanning (e.g., presence of metallic implants, pacemakers, intracranial structural abnormalities, severe claustrophobia) K. Currently participating in another clinical trial or has participated within the past 30 days L. Pregnant or breastfeeding M. Considered by the investigator to be unsuitable for participation in the study for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight Change | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric measurements: height, weight, waist circumference, hip circumference, waist-hip ratio (WHR), blood biomarkers: fasting glucose, HbA1c, triglycerides, HDL cholesterol, LDL cholesterol, total cholesterol, insulin, uric acid, high-sensitivity C-reactive protein (hs-CRP);Clinical rating scales: Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI), Global Assessment of Functioning (GAF), Eppendorf Schizophrenia Inventory (ESI), WHO Quality of Life-BREF (WHOQOL-BREF), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), Pittsburgh Sleep Quality Index (PSQI), Rosenberg Self-Esteem Scale (RSES), behavioral and lifestyle assessments: International Physical Activity Questionnaire (IPAQ), Korean version of the Eating Attitudes Test-26 (KEAT-26);fMRI (Functional Magnetic Resonance Imaging) | — |
Countries
Korea, Republic of
Contacts
Public ContactNa Yeon Kim
Chung-Ang Univerisity Hospital
Outcome results
None listed