The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
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ClinicalTrials.gov Identifier: NCT01654640 |
Recruitment Status
: Unknown
Verified December 2015 by Yong Min Ahn, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted
: August 1, 2012
Last Update Posted
: December 8, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Schizophrenia | Drug: Metformin Drug: Placebo (for metformin) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine |
Study Start Date : | July 2012 |
Estimated Primary Completion Date : | April 2016 |
Estimated Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Metformin group
Metformin 500mg 1 tablet p.o. bid
|
Drug: Metformin
metformin 500mg p.o. bid for 24 weeks
Other Name: Diabex
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Placebo Comparator: Placebo group
1 tablet p.o. bid
|
Drug: Placebo (for metformin)
placebo 1T bid
Other Name: placebo
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- change of weight [ Time Frame: baseline, 12 weeks, 24 weeks ]change of weight after 12-week, 24-week. calculation; (weight of 12-week - weight of baseline)/baseline weight (weight of 24-week - weight of baseline)/baseline weight
- Positive and Negative Symptom Scale(PANSS) [ Time Frame: baseline, 12 weeks, 24 weeks ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- MADRS(montgomery asberg depression rating scale) [ Time Frame: baseline, 12 weeks, 24 weeks ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- Clinical Global Impression-severity(CGI-S) [ Time Frame: baseline, 6 weeks, 24 weeks ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- Clinical Global Impression-improvement(CGI-I) [ Time Frame: baseline, 12 weeks, 24 weeks ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- Beck's Depression Inventory(BDI) [ Time Frame: baseline, 12 weeks, 24 weeks ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS) [ Time Frame: baseline, 12 weeks, 24 weeks ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- World Health Organization Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: baseline, 12 weeks, 24 weeks ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- Short form(36) Health survey (SF-36) [ Time Frame: baseline, 12 weeks, 24 weeks ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- abdominal fat amount CT [ Time Frame: baseline, 12 weeks, 24 weeks ]baseline, 12-week, 24-week
- change of prevalence of metabolic syndrome [ Time Frame: baseline, 12 weeks, 24 weeks ]waist circumference, blood pressure cholesterol,triglyceride, HDL-cholesterol,fasting glucose

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 18 ~ 65
- Patient with schizophrenia according to DSM-IV criteria
- Patient have signed on the informed consent, and well understood the objective and procedure of this study.
- Patient taking clozapine 3months or more
- Patient increased in weight more than 10 % of that of before antipsychotics use
Exclusion Criteria:
- Patient taking other antipsychotics with clozapine
- Patient in treatment of diabetes
- Patient in treatment of dyslipidemia
- Allergy or hypersensitivity to metformin
- Pregnant or breast-feeding female patient.
- Patient with severe medical condition

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654640
Contact: Hyun Jeong Lee, MD | hjlee.np@gmail.com |
Korea, Republic of | |
Seoul National University Hospital | Not yet recruiting |
Seoul, Korea, Republic of | |
Contact: Hyun Jeong Lee, MD hjlee.np@gmail.com | |
Principal Investigator: Yong Min Ahn, MD, PhD | |
Sub-Investigator: Hyun Jeong Lee, MD | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of | |
Principal Investigator: Yong Min Ahn, MD., PhD. |
Principal Investigator: | Yong Min Ahn, MD, PhD | Seoul National University Hospital |
Additional Information:
Responsible Party: | Yong Min Ahn, professor, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT01654640 History of Changes |
Other Study ID Numbers: |
DW_Metformin |
First Posted: | August 1, 2012 Key Record Dates |
Last Update Posted: | December 8, 2015 |
Last Verified: | December 2015 |
Keywords provided by Yong Min Ahn, Seoul National University Hospital:
schizophrenia obesity clozapine metformin |
Additional relevant MeSH terms:
Obesity Schizophrenia Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Metformin Clozapine Hypoglycemic Agents |
Physiological Effects of Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs GABA Antagonists GABA Agents |