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

Schizophrenia Clinical Trial

Official title:

Phase 4 Study of Metformin on Obesity and Metabolic Disturbance in Patients Taking Clozapine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01654640
• Other study ID #: DW_Metformin
• Status: Terminated
• Phase: Phase 4
• Start date: September 2012
• Est. completion date: April 2015

Study information

• Verified date: September 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Schizophrenia

Intervention

Drug:
• Metformin
metformin 500mg p.o. bid for 24 weeks
• Placebo (for metformin)
placebo 1T bid

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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

External Links

•   study site