Taipei Medical University-Wan Fang Hospital
Taipei, 116, Taiwan
NCT Number: NCT06326840
The goal of this clinical trial is to explore the potential of metformin in managing olanzapine-induced metabolic disturbance and hyperprolactinemia in patients with schizophrenia. The main questions it aims to answer are:
1. The effect of metformin on olanzapine-induced metabolic disturbance 2. The effect of metformin on olanzapine-induced hyperprolactinemia
Participants will receive metformin 1500 mg/day for 8 weeks and assessments every 2 weeks.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Taipei, 116, Taiwan
The study was conducted in an inpatient setting, with the dosage of olanzapine remaining consistent throughout the study duration. All participants were administered 1500 mg/day of metformin for eight weeks. Vital signs were measured daily. Physical and neurological examinations were carried out on a weekly basis. Every two weeks, all participants underwent an assessment for general psychopathology. Blood samples were collected in the morning after an overnight fast at the beginning of the study and then every two weeks following the commencement of metformin treatment. Serum prolactin levels were determined through electrochemiluminescence immunoassays. Fasting serum levels of glucose, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides were measured using enzymatic colorimetric assays. Serum insulin and leptin levels were measured using electrochemiluminescence immunoassay kits.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All participants were administered 1500 mg/day of metformin for eight weeks. The trial design is single-group with no masking.
Time frame: 8 weeks
Glucose level was measured every 2 weeks.
Time frame: 8 weeks
Prolactin level was assessed every 2 weeks.
Time frame: 8 weeks
insulin level was measured every 2 weeks
Time frame: 8 weeks
LDL-C level was measured every 2 weeks
Time frame: 8 weeks
HDL-C level was measured every 2 weeks
Time frame: 8 weeks
cholesterol level was measured every 2 weeks
Time frame: 8 weeks
triglycerides level was measured every 2 weeks
Time frame: 8 weeks
leptin level was measured every 2 weeks
Time frame: 8 weeks
The clinical global impression scale was applied every 2 weeks. The clinical global impression scale is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. The clinical global impression scale is rated from 0 (normal, not at all ill) to 7 (Among the most extremely ill patients).
Taipei Medical University Hospital
Other
Predictive Models of Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment
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