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

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ClinicalTrials.gov Identifier: NCT01654640
Recruitment Status : Unknown
Verified December 2015 by Yong Min Ahn, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : August 1, 2012
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
Daewoong Pharmaceutical Co. LTD.
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Metformin Drug: Placebo (for metformin) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine
Study Start Date : July 2012
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Positive and Negative Symptom Scale(PANSS) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)

  2. MADRS(montgomery asberg depression rating scale) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)

  3. Clinical Global Impression-severity(CGI-S) [ Time Frame: baseline, 6 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)

  4. Clinical Global Impression-improvement(CGI-I) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)

  5. Beck's Depression Inventory(BDI) [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 1-week, 4-week, 12-week, 24-week(end-point)

  6. 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)

  7. 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)

  8. 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)

  9. abdominal fat amount CT [ Time Frame: baseline, 12 weeks, 24 weeks ]
    baseline, 12-week, 24-week

  10. change of prevalence of metabolic syndrome [ Time Frame: baseline, 12 weeks, 24 weeks ]
    waist circumference, blood pressure cholesterol,triglyceride, HDL-cholesterol,fasting glucose


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
study site  This link exits the ClinicalTrials.gov site

Responsible Party: Yong Min Ahn, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01654640     History of Changes
Other Study ID Numbers: DW_Metformin
First Posted: August 1, 2012    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Yong Min Ahn, Seoul National University Hospital:
schizophrenia
obesity
clozapine
metformin

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