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The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine

This study is not yet open for participant recruitment.
Verified July 2012 by Seoul National University Hospital
Sponsor:
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: July 30, 2012
Last verified: July 2012
History of Changes

July 16, 2012
July 30, 2012
July 2012
February 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01654640 on ClinicalTrials.gov Archive Site
  • 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
Same as current
 
 
 
The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine

The purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Metformin
    metformin 500mg p.o. bid for 24 weeks
    Other Name: Diabex
  • Drug: Placebo (for metformin)
    placebo 1T bid
  • Experimental: Metformin group
    Metformin 500mg 1 tablet p.o. bid
    Intervention: Drug: Metformin
  • Placebo Comparator: Placebo group
    1 tablet p.o. bid
    Intervention: Drug: Placebo (for metformin)
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
April 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Hyun Jeong Lee, MD hjlee.np@gmail.com
Korea, Republic of
 
NCT01654640
DW_Metformin
Yes
Yong Min Ahn, Seoul National University Hospital
Seoul National University Hospital
Daewoong Pharmaceutical Co. LTD.
Principal Investigator: Yong Min Ahn, MD, PhD Seoul National University Hospital
Seoul National University Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP