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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: December 5, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Metformin
Drug: Placebo (for metformin)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

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


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


Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin group
Metformin 500mg 1 tablet p.o. bid
Drug: Metformin
metformin 500mg p.o. bid for 24 weeks
Other Name: Diabex
Placebo Comparator: Placebo group
1 tablet p.o. bid
Drug: Placebo (for metformin)
placebo 1T bid
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654640

Contacts
Contact: Hyun Jeong Lee, MD hjlee.np@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Hyun Jeong Lee, MD       hjlee.np@gmail.com   
Principal Investigator: Yong Min Ahn, MD, PhD         
Sub-Investigator: Hyun Jeong Lee, MD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Yong Min Ahn, MD., PhD.         
Sponsors and Collaborators
Seoul National University Hospital
Daewoong Pharmaceutical Co. LTD.
Investigators
Principal Investigator: Yong Min Ahn, MD, PhD Seoul National University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Yong Min Ahn, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01654640     History of Changes
Other Study ID Numbers: DW_Metformin
Study First Received: July 16, 2012
Last Updated: December 5, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
schizophrenia
obesity
clozapine
metformin

Additional relevant MeSH terms:
Obesity
Schizophrenia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Metformin
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on August 27, 2014