Status:
COMPLETED
The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study)
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00816907
Start Date
January 1 2009
End Date
March 1 2010
Last Update
March 27 2013
Active Locations (16)
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1
Stanford University
Palo Alto, California, United States, 94305
2
Mental Health Advocates
Boca Raton, Florida, United States, 33431
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Clinical Research Institute
Wichita, Kansas, United States, 67207