The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study)
Overview[ - collapse ][ - ]
| Purpose | This study will test the usefulness of the medication metformin in treating people with schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic medications. |
|---|---|
| Condition | Schizophrenia |
| Intervention | Drug: Metformin Drug: Placebo |
| Phase | Phase 4 |
| Sponsor | National Institute of Mental Health (NIMH) |
| Responsible Party | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier | NCT00816907 |
| First Received | January 2, 2009 |
| Last Updated | February 13, 2013 |
| Last verified | November 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | January 2, 2009 |
|---|---|
| Last Updated Date | February 13, 2013 |
| Start Date | January 2009 |
| Estimated Primary Completion Date | March 2010 |
| Current Primary Outcome Measures | Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo [Time Frame: Measured at the last study visit] [Designated as safety issue: No]Mean difference in body weight change between participants assigned to metformin and participants assigned to placebo from baseline to last study visit (up to 16 weeks) |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study) |
|---|---|
| Official Title | Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (METS) - Pilot Study |
| Brief Summary | This study will test the usefulness of the medication metformin in treating people with schizophrenia or schizoaffective disorder who are overweight and also taking antipsychotic medications. |
| Detailed Description | Schizophrenia is a chronic mental disorder that is characterized, in part, by psychotic symptoms. Psychotic symptoms include hallucinations and delusions, in which a person has abnormal experiences or beliefs, and are commonly treated with antipsychotic medications. Unfortunately, a side effect of many antipsychotics is unwanted weight gain, which can lead to physical illness. Use of the drug metformin has resulted in weight loss among diabetics. Metformin has also been shown to cause weight loss in preliminary studies of people taking atypical antipsychotics—a newer, second generation of antipsychotic medications. Metformin is currently approved by the Food and Drug Administration to treat only people with diabetes. This study will test the usefulness of prescribing metformin as a second medication to treat people with schizophrenia or schizoaffective disorder who are overweight and taking antipsychotics. The study will also provide important feasibility information for future larger studies. Participation in this study will last 16 weeks. After undergoing baseline assessments, participants will be randomly assigned to receive either metformin or placebo, both of which will be taken twice daily for the duration of the study. All participants will also receive behavioral therapy that will teach them about reducing their weight through diet and exercise. Participants will undergo assessments at 11 study visits: the first 2 will include screening and baseline testing, the next 2 visits will take place after the first and second weeks of receiving treatment, and the last 7 visits will take place every 2 weeks until the end of the study. Assessments will include measurements of body weight, waist-to-hip ratio, and vital signs; clinical interviews about medication adherence, side effects, and alcohol use; and monthly blood tests to assess levels of lipids, glucose, insulin, and hemoglobin A1c. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Schizophrenia |
| Intervention | Drug: Metformin 500 mg to 1,000 mg taken twice daily for 16 weeks Other Names: GlucophageDrug: Placebo 1 to 2 placebo capsules taken twice daily for 16 weeks Other Names: Placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 146 |
| Estimated Completion Date | March 2010 |
| Estimated Primary Completion Date | February 2010 |
| Eligibility Criteria | Inclusion Criteria: - Outpatients with a diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID) - Duration of illness greater than 1 year, as defined by having initiated antipsychotic treatment at least 1 year prior to study entry - Adequate decisional capacity to make a choice about participating in this research study - Body mass index (BMI) at or greater than 27 - Currently being treated with one or a combination of two antipsychotic medications (typical or atypical) and on that drug regimen for at least 2 months prior to study entry, with stable dosages for at least 1 month - If taking antidepressants, mood stabilizers, or anxiolytics, the dose must be stable for at least 1 month prior to study entry - Willing to use an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study. Acceptable methods include oral, injectable, or implanted contraceptives; intrauterine devices or barrier methods such as condoms; and diaphragms and spermicides. Exclusion Criteria: - Inpatient status - Clinical Global Impression Severity (CGI-S) score greater than 6 - Currently being treated with more than two antipsychotic medications - Fasting glucose greater than 125 - Diagnosis of diabetes mellitus or treatment with insulin or oral hypoglycemics - Previous or current treatment with metformin - Diagnosis of congestive heart failure - Renal impairment, as defined by a serum creatinine level greater than 1.5 in males or greater than 1.4 in females, or creatinine estimated glomerular filtration rate (GFR) outside of normal limits - Hepatic disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), or c-glutamyl transferase (CGT) greater than 1.5 times upper limit of normal (ULN), or total bilirubin greater than 1.2 times ULN - Metabolic acidosis, as defined by serum carbon dioxide less than the lower limit of normal - Known hypersensitivity to metformin - Pregnant or breastfeeding - Recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material - Alcohol abuse or dependence within the past month, as determined by the SCID - Other serious and unstable medical condition in the judgment of the investigator - Diagnosis of mental retardation, delirium, or dementia, as defined by DSM-IV-TR - Failed to discontinue 4 weeks prior to study entry any medication used for weight loss - Concurrent treatment with certain drugs that are known to increase metformin blood levels should be discussed with the Project Medical Officer. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00816907 |
|---|---|
| Other Study ID Numbers | N01 MH090001-03 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | National Institute of Mental Health (NIMH) |
| Study Sponsor | National Institute of Mental Health (NIMH) |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: L. Fredrik Jarskog, MD Columbia UniversityPrincipal Investigator: Jeffrey A. Lieberman, MD Columbia UniversityPrincipal Investigator: T. Scott Stroup, MD, MPH Columbia University |
| Verification Date | November 2010 |
Locations[ + expand ][ + ]
| Stanford University | Palo Alto, California, United States, 94305 |
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| Mental Health Advocates | Boca Raton, Florida, United States, 33431 |
| University of Iowa | Iowa City, Iowa, United States, 52242 |
| Clinical Research Institute | Wichita, Kansas, United States, 67207 |
| Clinical Insights | Glen Burnie, Maryland, United States, 21061 |
| Freedom Trail Clinic | Boston, Massachusetts, United States, 02114 |
| University of Massachusetts | Worcester, Massachusetts, United States, 01605 |
| University of Minnesota School of Medicine | Minneapolis, Minnesota, United States, 55454 |
| New Mexico VA Healthcare System | Albuquerque, New Mexico, United States, 87108 |
| Research Foundation for Mental Hygiene | New York, New York, United States, 10032 |
| University of Rochester | Rochester, New York, United States, 14623 |
| University of Cincinnati | Cincinnati, Ohio, United States, 45267 |
| Vanderbilt University Schizophrenia Research | Nashville, Tennessee, United States, 37212 |
| University of Texas Southwestern Medical Center | Dallas, Texas, United States, 75235 |
| Baylor College of Medicine | Houston, Texas, United States, 77030 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas, United States, 78229 |