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

Seoul National University

Status and phase: Terminated; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Placebo (for metformin); Drug: Metformin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01654640

DW_Metformin

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Metformin group

Experimental group

Description:

Metformin 500mg 1 tablet p.o. bid

Treatment:

Drug: Metformin

Placebo group

Placebo Comparator group

Description:

1 tablet p.o. bid

Treatment:

Drug: Placebo (for metformin)