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

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Metformin
Placebo (for metformin)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, obesity, clozapine, metformin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin group

Placebo group

Arm Description

Metformin 500mg 1 tablet p.o. bid

1 tablet p.o. bid

Outcomes

Primary Outcome Measures

change of weight
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)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
MADRS(montgomery asberg depression rating scale)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Clinical Global Impression-severity(CGI-S)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Clinical Global Impression-improvement(CGI-I)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Beck's Depression Inventory(BDI)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
Short form(36) Health survey (SF-36)
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
abdominal fat amount CT
baseline, 12-week, 24-week
change of prevalence of metabolic syndrome
waist circumference, blood pressure cholesterol,triglyceride, HDL-cholesterol,fasting glucose

Full Information

First Posted
July 16, 2012
Last Updated
September 5, 2018
Sponsor
Seoul National University Hospital
Collaborators
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT01654640
Brief Title
The Effect of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
Official Title
Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Failure to recruit the planned number of participants
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, obesity, clozapine, metformin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Min Ahn, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://www.snuh.org/
Description
study site

Learn more about this trial

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

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