The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine. |
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Condition | Schizophrenia |
Intervention | Drug: Metformin Drug: Placebo (for metformin) |
Phase | Phase 4 |
Sponsor | Seoul National University Hospital |
Responsible Party | Seoul National University Hospital |
ClinicalTrials.gov Identifier | NCT01654640 |
First Received | July 16, 2012 |
Last Updated | December 5, 2013 |
Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | July 16, 2012 |
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Last Updated Date | December 5, 2013 |
Start Date | July 2012 |
Estimated Primary Completion Date | April 2015 |
Current 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 |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine |
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Official Title | Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine |
Brief Summary | The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine. |
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. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Schizophrenia |
Intervention | Drug: Metformin metformin 500mg p.o. bid for 24 weeks Other Names: DiabexDrug: Placebo (for metformin) placebo 1T bid Other Names: placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 30 |
Estimated Completion Date | April 2015 |
Estimated Primary Completion Date | February 2015 |
Eligibility 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Hyun Jeong Lee, MD hjlee.np@gmail.com |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01654640 |
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Other Study ID Numbers | DW_Metformin |
Has Data Monitoring Committee | Yes |
Information Provided By | Seoul National University Hospital |
Study Sponsor | Seoul National University Hospital |
Collaborators | Daewoong Pharmaceutical Co. LTD. |
Investigators | Principal Investigator: Yong Min Ahn, MD, PhD Seoul National University Hospital |
Verification Date | December 2013 |
Locations[ + expand ][ + ]
Seoul National University Hospital | Seoul, Korea, Republic of Contact: Hyun Jeong Lee, MD | hjlee.np@gmail.comPrincipal Investigator: Yong Min Ahn, MD, PhD Not yet recruiting |
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Seoul National University Hospital | Seoul, Korea, Republic of Principal Investigator: Yong Min Ahn, MD., PhD.Recruiting |