An interventional study of Metformin in Metabolic Disturbance, Hyperprolactinemia and Schizophrenia, sponsored by Taipei Medical University Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by Taipei Medical University Hospital · Not applicable, Interventional, and Treatment
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:
Participants will receive metformin 1500 mg/day for 8 weeks and assessments every 2 weeks.
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.
39 studies on the registry are indexed under Hyperprolactinemia; 4 are open to participants now.
This study's enrollment of 42 is below the median of 60 across 20 interventional studies indexed under Hyperprolactinemia.
Browse Hyperprolactinemia studies →Taipei Medical University Hospital is the lead sponsor of 64 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants were administered 1500 mg/day of metformin for eight weeks.
Drug: Metformin
All participants were administered 1500 mg/day of metformin for eight weeks. The trial design is single-group with no masking.
Glucose level
Glucose level was measured every 2 weeks.
Time frame: 8 weeks
prolactin level
Prolactin level was assessed every 2 weeks.
Time frame: 8 weeks
Insulin level
insulin level was measured every 2 weeks
Time frame: 8 weeks
low-density lipoprotein cholesterol (LDL-C) level
LDL-C level was measured every 2 weeks
Time frame: 8 weeks
high-density lipoprotein cholesterol (HDL-C) level
HDL-C level was measured every 2 weeks
Time frame: 8 weeks
cholesterol level
cholesterol level was measured every 2 weeks
Time frame: 8 weeks
triglycerides level
triglycerides level was measured every 2 weeks
Time frame: 8 weeks
leptin level
leptin level was measured every 2 weeks
Time frame: 8 weeks
Clinical Global Impression scale
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).
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin
Taipei Medical University Hospital