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

NCT01654640 | Terminated Phase 4 DMC

• 1 other identifier: DW_Metformin
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

schizophrenia; obesity; clozapine; metformin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Positive and Negative Symptom Scale(PANSS)

  baseline, 12 weeks, 24 weeks

• MADRS(montgomery asberg depression rating scale)

  baseline, 12 weeks, 24 weeks

• Clinical Global Impression-severity(CGI-S)

  baseline, 6 weeks, 24 weeks

• Clinical Global Impression-improvement(CGI-I)

  baseline, 12 weeks, 24 weeks

• Beck's Depression Inventory(BDI)

  baseline, 12 weeks, 24 weeks

Study Arms (2)

Metformin group

EXPERIMENTAL

Metformin 500mg 1 tablet p.o. bid

Drug: Metformin

Placebo group

PLACEBO COMPARATOR

1 tablet p.o. bid

Drug: Placebo (for metformin)

Interventions

Metformin DRUG

metformin 500mg p.o. bid for 24 weeks

Also known as: Diabex

Metformin group

Placebo (for metformin) DRUG

placebo 1T bid

Also known as: placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Daewoong Pharmaceutical Co. LTD.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Links

• study site

MeSH Terms

Conditions

Schizophrenia; Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Yong Min Ahn, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: August 1, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

KR (1)