Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment

Predictive Models of Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Metabolic Disturbance; Hyperprolactinemia
• Intervention / Treatment: Drug: Metformin

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 116
    • Taipei Medical University-Wan Fang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: metformin intervention; All participants were administered 1500 mg/day of metformin for eight weeks.	Drug: Metformin; All participants were administered 1500 mg/day of metformin for eight weeks. The trial design is single-group with no masking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose level	Glucose level was measured every 2 weeks.	8 weeks
prolactin level	Prolactin level was assessed every 2 weeks.	8 weeks
Insulin level	insulin level was measured every 2 weeks	8 weeks
low-density lipoprotein cholesterol (LDL-C) level	LDL-C level was measured every 2 weeks	8 weeks
high-density lipoprotein cholesterol (HDL-C) level	HDL-C level was measured every 2 weeks	8 weeks
cholesterol level	cholesterol level was measured every 2 weeks	8 weeks
triglycerides level	triglycerides level was measured every 2 weeks	8 weeks
leptin level	leptin level was measured every 2 weeks	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Collaborators: Taipei Medical University
• Investigators: Principal Investigator: Mong-Liang Lu, MD, Taipei Meidcal University-Wan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2010
• Primary Completion (Actual): June 10, 2011
• Study Completion (Actual): June 10, 2011

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 17, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: schizophrenia; olanzapine; prolactin; metabolic disturbance
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Hypothalamic Diseases; Hyperpituitarism; Pituitary Diseases; Schizophrenia; Hyperprolactinemia; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 98107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No