The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study)

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00816907

Run by

National Institute of Mental Health (NIMH)

People needed

146

Starts

2009-01-01

Expected to finish

2010-03-01

Last updated by the study team

2013-03-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University — Palo Alto, California, United States
• Mental Health Advocates — Boca Raton, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Clinical Research Institute — Wichita, Kansas, United States
• Clinical Insights — Glen Burnie, Maryland, United States
• Freedom Trail Clinic — Boston, Massachusetts, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• University of Minnesota School of Medicine — Minneapolis, Minnesota, United States
• New Mexico VA Healthcare System — Albuquerque, New Mexico, United States
• Research Foundation for Mental Hygiene — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Vanderbilt University Schizophrenia Research — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.