Metformin for Weight Loss in Schizophrenia
Overview[ - collapse ][ - ]
Purpose | Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism. |
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Condition | Schizophrenia Obesity |
Intervention | Drug: Metformin |
Phase | N/A |
Sponsor | Nathan Kline Institute for Psychiatric Research |
Responsible Party | Nathan Kline Institute for Psychiatric Research |
ClinicalTrials.gov Identifier | NCT01177709 |
First Received | April 23, 2010 |
Last Updated | May 16, 2012 |
Last verified | May 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | April 23, 2010 |
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Last Updated Date | May 16, 2012 |
Start Date | May 2000 |
Estimated Primary Completion Date | April 2011 |
Current Primary Outcome Measures | Weight in lbs. [Time Frame: baseline, 4 wks, 8 wks, 12 weeks] [Designated as safety issue: No]Patients weight in pounds |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Metformin for Weight Loss in Schizophrenia |
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Official Title | Evaluation of the Efficacy of Metformin for Weight Loss and Metabolic Effects In Overweight Psychiatric Patients Treated With Antipsychotic Medication |
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 | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Metformin metformin 500- 2500 mg/day. |
Study Arm (s) | Experimental: Metformin |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 15 |
Estimated Completion Date | April 2011 |
Estimated Primary Completion Date | April 2011 |
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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01177709 |
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Other Study ID Numbers | 091/C22 |
Has Data Monitoring Committee | No |
Information Provided By | Nathan Kline Institute for Psychiatric Research |
Study Sponsor | Nathan Kline Institute for Psychiatric Research |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | May 2012 |
Locations[ + expand ][ + ]
Manhatan Psychiatric Center | New York, New York, United States, 10035 |
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