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.
ConditionSchizophrenia
InterventionDrug: Metformin
Drug: Placebo (for metformin)
PhasePhase 4
SponsorSeoul National University Hospital
Responsible PartySeoul National University Hospital
ClinicalTrials.gov IdentifierNCT01654640
First ReceivedJuly 16, 2012
Last UpdatedDecember 5, 2013
Last verifiedDecember 2013

Tracking Information[ + expand ][ + ]

First Received DateJuly 16, 2012
Last Updated DateDecember 5, 2013
Start DateJuly 2012
Estimated Primary Completion DateApril 2015
Current Primary Outcome Measureschange 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
  • 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

Descriptive Information[ + expand ][ + ]

Brief TitleThe Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
Official TitlePhase 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 TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionSchizophrenia
InterventionDrug: Metformin
metformin 500mg p.o. bid for 24 weeks
Other Names:
DiabexDrug: Placebo (for metformin)
placebo 1T bid
Other Names:
placebo
Study Arm (s)
  • Experimental: Metformin group
    Metformin 500mg 1 tablet p.o. bid
  • Placebo Comparator: Placebo group
    1 tablet p.o. bid

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment30
Estimated Completion DateApril 2015
Estimated Primary Completion DateFebruary 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Hyun Jeong Lee, MD
hjlee.np@gmail.com
Location CountriesKorea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT01654640
Other Study ID NumbersDW_Metformin
Has Data Monitoring CommitteeYes
Information Provided BySeoul National University Hospital
Study SponsorSeoul National University Hospital
CollaboratorsDaewoong Pharmaceutical Co. LTD.
Investigators Principal Investigator: Yong Min Ahn, MD, PhD Seoul National University Hospital
Verification DateDecember 2013

Locations[ + expand ][ + ]

Seoul National University Hospital
Seoul, Korea, Republic of
Contact: Hyun Jeong Lee, MD | hjlee.np@gmail.com
Principal Investigator: Yong Min Ahn, MD, PhD
Not yet recruiting
Seoul National University Hospital
Seoul, Korea, Republic of
Principal Investigator: Yong Min Ahn, MD., PhD.
Recruiting