Back to resultsMetformin for Weight Loss in Schizophrenia
Primary Purpose
Schizophrenia, Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, antipsychotics, obesity, diabetes
Eligibility Criteria
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.
Sites / Locations
- Manhatan Psychiatric Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metformin
Arm Description
Outcomes
Primary Outcome Measures
Weight (wt) in Pounds (Lbs)..
Patients weight in pounds
Secondary Outcome Measures
Glucose Levels
Fasting glucose
Insulin Level
fasting serum insulin uIU/ml.
Full Information
NCT ID
NCT01177709
First Posted
April 23, 2010
Last Updated
August 2, 2017
Sponsor
Nathan Kline Institute for Psychiatric Research
1. Study Identification
Unique Protocol Identification Number
NCT01177709
Brief Title
Metformin for Weight Loss in Schizophrenia
Official Title
Evaluation of the Efficacy of Metformin for Weight Loss and Metabolic Effects In Overweight Psychiatric Patients Treated With Antipsychotic Medication
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
PI moved to different institution. Decided to concentrate on different studies.
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nathan Kline Institute for Psychiatric Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Obesity
Keywords
schizophrenia, antipsychotics, obesity, diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
metformin 500- 2500 mg/day. Patient received variable doses of metformin starting at 500 mg/day and increasing up to maximum of 2500 mg/day over 3-4 weeks. Dose was titrated on tolerability and side effects, especially development of hypoglycemia. This explains why different patients received different maximum doses.
Primary Outcome Measure Information:
Title
Weight (wt) in Pounds (Lbs)..
Description
Patients weight in pounds
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Glucose Levels
Description
Fasting glucose
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Insulin Level
Description
fasting serum insulin uIU/ml.
Time Frame
baseline, 4 weks, 8 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C. Smith, MD PHD
Organizational Affiliation
Nathan Kline Institute for Psychiatric Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhatan Psychiatric Center
City
New York
State/Province
New York
ZIP/Postal Code
10035
Country
United States
12. IPD Sharing Statement
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Metformin for Weight Loss in Schizophrenia
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