Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment

Schizophrenia Clinical Trial

Official title:

Predictive Models of Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06326840
• Other study ID #: 98107
• Status: Completed
• Phase: N/A
• Start date: May 31, 2010
• Est. completion date: June 10, 2011

Study information

• Verified date: May 2010
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 10, 2011
• Est. primary completion date: June 10, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperprolactinemia
• Metabolic Disturbance
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei Medical University-Wan Fang Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University Hospital	Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose level	Glucose level was measured every 2 weeks.	8 weeks
Primary	prolactin level	Prolactin level was assessed every 2 weeks.	8 weeks
Primary	Insulin level	insulin level was measured every 2 weeks	8 weeks
Primary	low-density lipoprotein cholesterol (LDL-C) level	LDL-C level was measured every 2 weeks	8 weeks
Primary	high-density lipoprotein cholesterol (HDL-C) level	HDL-C level was measured every 2 weeks	8 weeks
Primary	cholesterol level	cholesterol level was measured every 2 weeks	8 weeks
Primary	triglycerides level	triglycerides level was measured every 2 weeks	8 weeks
Primary	leptin level	leptin level was measured every 2 weeks	8 weeks
Secondary	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