Metformin for Weight Loss in Schizophrenia

Obesity Clinical Trial

Official title:

Evaluation of the Efficacy of Metformin for Weight Loss and Metabolic Effects In Overweight Psychiatric Patients Treated With Antipsychotic Medication

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01177709
• Other study ID #: 091/C22
• Status: Terminated
• Phase: N/A
• First received: April 23, 2010
• Last updated: May 16, 2012
• Start date: May 2000
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• Source: Nathan Kline Institute for Psychiatric Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients will be 18-70 years of age;

• Currently hospitalized or an outpatient at MPC;

• BMI = 35 or excessive recent weight gain ( > than 10 lb weight gain in the past 3 months);

• Patients will have a diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder.

Exclusion Criteria:

• Age below 18 or over 70;

• Patient is currently already treated with metformin.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Schizophrenia

Intervention

Drug:
• Metformin
metformin 500- 2500 mg/day.

Locations

Country	Name	City	State
United States	Manhatan Psychiatric Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Nathan Kline Institute for Psychiatric Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight in lbs.	Patients weight in pounds	baseline, 4 wks, 8 wks, 12 weeks	No
Secondary	Glucose levels	Fasting glucose	baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Insulin Level	fasting serum insulin	baseline, 4 weks, 8 weeks, 12 weeks	No
Secondary	Glucose tolerance test restuls	glucose and insulin levels from 75 gm glucose tolerance test at baseline and 3 months	baseline and 3 months(12 weeks)	No
Secondary	cognitive function on memory tests	scores on two cognitive tests RBANS and spatial and letter span section form MATRICS battery	baseline and 3 months	No
Secondary	cognitive function on memory tests	scores on two cognitive tests RBANS and spatial and letter span section form MATRICS battery	baseline and 3 months ( 12 weeks)	No