Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment

Taipei Medical University Hospital42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metabolic Disturbance Hyperprolactinemia Schizophrenia

Interventions

MetforminDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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: * Exclusion criteria encompassed any mental disorder other than schizophrenia, ongoing substance abuse, and medical conditions that could interfere with glucoregulatory and endocrine assessment such as diabetes mellitus and other endocrine disorders. Additionally, severe cardiovascular, hepatic, or renal diseases, malignancy, epilepsy, and pregnancy were also reasons for exclusion.

Locations (1)

Taipei Medical University-Wan Fang Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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