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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 

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
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