Metformin for Weight Loss in Schizophrenia

Not Applicable

Terminated

• Conditions: Schizophrenia; Obesity
• Interventions: Drug: Metformin

• Registration Number: NCT01177709
• Lead Sponsor: Nathan Kline Institute for Psychiatric Research

Brief Summary

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

Detailed Description

Patients who had gained more than 10 lbs of weight in the last 3 months or had BMI of 35 or greater were treated with metformin up to 2500 mg/day in an open label study of up to 3 months time. Changes in weight and glucose measures were recorded.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2016-12-15
• Results First Submitted QC: 2016-12-15
• Results First Posted: 2017-02-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

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Exclusion Criteria

• Age below 18 or over 70;
• Patient is currently already treated with metformin.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
Weight (wt) in Pounds (Lbs)..	baseline, 4 weeks, 8 weeks, 12 weeks	Patients weight in pounds

Secondary Outcome Measures

Name	Time	Method
Glucose Levels	baseline, 4 weeks, 8 weeks, 12 weeks	Fasting glucose
Insulin Level	baseline, 4 weks, 8 weeks, 12 weeks	fasting serum insulin uIU/ml.

Trial Locations

Locations (1)

Manhatan Psychiatric Center; 🇺🇸 New York, New York, United States