Clinical trial

Predictive Models of Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment

Name
98107
Description
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.
Trial arms
Trial start
2010-05-31
Estimated PCD
2011-06-10
Trial end
2011-06-10
Status
Completed
Treatment
Metformin
All participants were administered 1500 mg/day of metformin for eight weeks. The trial design is single-group with no masking.
Arms:
metformin intervention
Size
42
Primary endpoint
Glucose level
8 weeks
prolactin level
8 weeks
Insulin level
8 weeks
low-density lipoprotein cholesterol (LDL-C) level
8 weeks
high-density lipoprotein cholesterol (HDL-C) level
8 weeks
cholesterol level
8 weeks
triglycerides level
8 weeks
leptin level
8 weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 42, 'type': 'ACTUAL'}}
Updated at
2024-03-22

1 organization

1 drug

3 indications

Indication
Schizophrenia