Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment
Predictive Models of Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment
1 other identifier
interventional
42
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2011
CompletedFirst Submitted
Initial submission to the registry
February 23, 2024
CompletedFirst Posted
Study publicly available on registry
March 22, 2024
CompletedMarch 22, 2024
May 1, 2010
1 year
February 23, 2024
March 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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 Outcomes (1)
Clinical Global Impression scale
8 weeks
Study Arms (1)
metformin intervention
EXPERIMENTALAll participants were administered 1500 mg/day of metformin for eight weeks.
Interventions
All participants were administered 1500 mg/day of metformin for eight weeks. The trial design is single-group with no masking.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei Medical University Hospitallead
- Taipei Medical Universitycollaborator
Study Sites (1)
Taipei Medical University-Wan Fang Hospital
Taipei, 116, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mong-Liang Lu, MD
Taipei Meidcal University-Wan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2024
First Posted
March 22, 2024
Study Start
May 31, 2010
Primary Completion
June 10, 2011
Study Completion
June 10, 2011
Last Updated
March 22, 2024
Record last verified: 2010-05
Data Sharing
- IPD Sharing
- Will not share