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Completed

NCT Number: NCT06326840

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University-Wan Fang Hospital

Taipei, 116, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

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

Primary outcomes

  1. Glucose level

    Time frame: 8 weeks

    Glucose level was measured every 2 weeks.

  2. prolactin level

    Time frame: 8 weeks

    Prolactin level was assessed every 2 weeks.

  3. Insulin level

    Time frame: 8 weeks

    insulin level was measured every 2 weeks

  4. low-density lipoprotein cholesterol (LDL-C) level

    Time frame: 8 weeks

    LDL-C level was measured every 2 weeks

  5. high-density lipoprotein cholesterol (HDL-C) level

    Time frame: 8 weeks

    HDL-C level was measured every 2 weeks

  6. cholesterol level

    Time frame: 8 weeks

    cholesterol level was measured every 2 weeks

  7. triglycerides level

    Time frame: 8 weeks

    triglycerides level was measured every 2 weeks

  8. leptin level

    Time frame: 8 weeks

    leptin level was measured every 2 weeks

Secondary outcomes

  1. Clinical Global Impression scale

    Time frame: 8 weeks

    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).

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Collaborators

  • Taipei Medical University

Registry information

Official study title

Predictive Models of Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 22, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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