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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Mental Health (NIMH)
• Treatments: Antipsychotic Agents; Metformin

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.