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| Name | Class |
|---|---|
| Taipei Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin intervention | Experimental | All participants were administered 1500 mg/day of metformin for eight weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | All participants were administered 1500 mg/day of metformin for eight weeks. The trial design is single-group with no masking. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose level | Glucose level was measured every 2 weeks. | 8 weeks |
| prolactin level | Prolactin level was assessed every 2 weeks. | 8 weeks |
| Insulin level | insulin level was measured every 2 weeks | 8 weeks |
| low-density lipoprotein cholesterol (LDL-C) level | LDL-C level was measured every 2 weeks | 8 weeks |
| high-density lipoprotein cholesterol (HDL-C) level | HDL-C level was measured every 2 weeks | 8 weeks |
| cholesterol level | cholesterol level was measured every 2 weeks | 8 weeks |
| triglycerides level | triglycerides level was measured every 2 weeks | 8 weeks |
| leptin level | leptin level was measured every 2 weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mong-Liang Lu, MD | Taipei Meidcal University-Wan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University-Wan Fang Hospital | Taipei | 116 | Taiwan |
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| ID | Term |
|---|---|
| D006966 | Hyperprolactinemia |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |