Phase 4
Completed N=146
The Use of Metformin in the Treatment of Antipsychotic-Induced Weight Gain in Schizophrenia (The METS Study)
Source: ClinicalTrials.gov NCT00816907 ↗Enrolled (actual)
146
Serious AEs
6.9%
Results posted
Mar 2013
Primary outcomePrimary: Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo — -1.0; -3.0 kilograms
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference in Body Weight Change Between Participants Assigned to Metformin and Participants Assigned to Placebo |
-1.0; -3.0 | — |
| SECONDARY Change in Total Cholesterol From Baseline to 16 Weeks |
0.2; -8.9 | — |
| SECONDARY Change in HDL Cholesterol From Baseline to 16 Weeks |
-0.4; -0.6 | — |
| SECONDARY Change in LDL Cholesterol From Baseline to 16 Weeks |
-2.0; -7.1 | — |
| SECONDARY Change in Triglycerides From Baseline to 16 Weeks |
13.2; -7.0 | — |
| SECONDARY Change in Fasting Glucose From Baseline to 16 Weeks |
-1.6; -2.3 | — |
| SECONDARY Change in Fasting Insulin From Baseline to 16 Weeks |
5.5; 1.6 | — |
| SECONDARY Change in Hemoglobin A1c From Baseline to 16 Weeks |
0.01; -0.06 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00816907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.