Hyperprolactinemia, Metabolic Disturbance, Schizophrenia
Conditions
Keywords
schizophrenia, olanzapine, metabolic disturbance, prolactin
Brief summary
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.
Detailed description
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.
Interventions
DRUGMetformin
All participants were administered 1500 mg/day of metformin for eight weeks. The trial design is single-group with no masking.
Sponsors
Taipei Medical University
Taipei Medical University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* aged between 18 and 60 years * diagnosed with schizophrenia under the Diagnostic and Statistical Manual of Mental Disorders-fourth edition criteria * had been consistently treated with a stable dose of olanzapine for a minimum of three months
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose level | 8 weeks | Glucose level was measured every 2 weeks. |
| prolactin level | 8 weeks | Prolactin level was assessed every 2 weeks. |
| Insulin level | 8 weeks | insulin level was measured every 2 weeks |
| low-density lipoprotein cholesterol (LDL-C) level | 8 weeks | LDL-C level was measured every 2 weeks |
| high-density lipoprotein cholesterol (HDL-C) level | 8 weeks | HDL-C level was measured every 2 weeks |
| cholesterol level | 8 weeks | cholesterol level was measured every 2 weeks |
| triglycerides level | 8 weeks | triglycerides level was measured every 2 weeks |
| leptin level | 8 weeks | leptin level was measured every 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression scale | 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). |
Countries
Taiwan
Outcome results
None listed