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

September 5, 2018 updated by: Yong Min Ahn, Seoul National University Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin group
Metformin 500mg 1 tablet p.o. bid
Drug: Metformin
metformin 500mg p.o. bid for 24 weeks
Other Names:
  • Diabex
Placebo Comparator: Placebo group
1 tablet p.o. bid
Drug: Placebo (for metformin)
placebo 1T bid
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of weight
Time Frame: baseline, 12 weeks, 24 weeks
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
baseline, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Symptom Scale(PANSS)
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
baseline, 12 weeks, 24 weeks
MADRS(montgomery asberg depression rating scale)
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
baseline, 12 weeks, 24 weeks
Clinical Global Impression-severity(CGI-S)
Time Frame: baseline, 6 weeks, 24 weeks
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
baseline, 6 weeks, 24 weeks
Clinical Global Impression-improvement(CGI-I)
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
baseline, 12 weeks, 24 weeks
Beck's Depression Inventory(BDI)
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
baseline, 12 weeks, 24 weeks
Liverpool University Neuroleptic Side Effect Rating Scale(LUNSERS)
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
baseline, 12 weeks, 24 weeks
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
baseline, 12 weeks, 24 weeks
Short form(36) Health survey (SF-36)
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 1-week, 4-week, 12-week, 24-week(end-point)
baseline, 12 weeks, 24 weeks
abdominal fat amount CT
Time Frame: baseline, 12 weeks, 24 weeks
baseline, 12-week, 24-week
baseline, 12 weeks, 24 weeks
change of prevalence of metabolic syndrome
Time Frame: baseline, 12 weeks, 24 weeks
waist circumference, blood pressure cholesterol,triglyceride, HDL-cholesterol,fasting glucose
baseline, 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Daewoong Pharmaceutical Co. LTD.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (Estimate)

August 1, 2012

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_Metformin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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