NCT06326840

Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment

Predictive Models of Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Taipei Medical University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Disturbance
• Hyperprolactinemia
• Schizophrenia

Interventions

Type	Name	Description
DRUG	Metformin	All participants were administered 1500 mg/day of metformin for eight weeks. The trial design is single-group with no masking.

Timeline

• Start date: 2010-05-31
• Primary completion: 2011-06-10
• Completion: 2011-06-10
• First posted: 2024-03-22
• Last updated: 2024-03-22

Locations

1 site across 1 country: Taiwan