The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
This study is currently recruiting participants.
(see Contacts and Locations)
Verified December 2015 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Collaborator:
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01654640
First received: July 16, 2012
Last updated: December 7, 2015
Last verified: December 2015
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Purpose
The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Metformin Drug: Placebo (for metformin) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine |
Resource links provided by NLM:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
U.S. FDA Resources
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- change of weight [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Positive and Negative Symptom Scale(PANSS) [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- MADRS(montgomery asberg depression rating scale) [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- Clinical Global Impression-severity(CGI-S) [ Time Frame: baseline, 6 weeks, 24 weeks ] [ Designated as safety issue: No ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- Clinical Global Impression-improvement(CGI-I) [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- Beck's Depression Inventory(BDI) [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]baseline, 1-week, 4-week, 12-week, 24-week(end-point)
- abdominal fat amount CT [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]baseline, 12-week, 24-week
- change of prevalence of metabolic syndrome [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]waist circumference, blood pressure cholesterol,triglyceride, HDL-cholesterol,fasting glucose
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metformin group
Metformin 500mg 1 tablet p.o. bid
|
Drug: Metformin
metformin 500mg p.o. bid for 24 weeks
Other Name: Diabex
|
|
Placebo Comparator: Placebo group
1 tablet p.o. bid
|
Drug: Placebo (for metformin)
placebo 1T bid
Other Name: placebo
|
Detailed Description:
In this study, the investigators are going to examine the effect of metformin on obesity and metabolic disturbance in patients with schizophrenia who have taken clozapine.The metformin 500mg will be administrated per oral twice a day for 24 weeks and for control group, placebo will be given same route and process.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654640
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654640
Contacts
| Contact: Hyun Jeong Lee, MD | hjlee.np@gmail.com |
Locations
| 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. | |
Sponsors and Collaborators
Seoul National University Hospital
Daewoong Pharmaceutical Co. LTD.
Investigators
| Principal Investigator: | Yong Min Ahn, MD, PhD | Seoul National University Hospital |
More Information
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 |
| Study First Received: | July 16, 2012 |
| Last Updated: | December 7, 2015 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 28, 2016