Adjunctive Low-dose Metformin in Patients With Schizophrenia and Metabolic Abnormalities (NCT02751307) | Clinical Trial Compass
CompletedPhase 4
Adjunctive Low-dose Metformin in Patients With Schizophrenia and Metabolic Abnormalities
55 participantsStarted 2013-05
Plain-language summary
Metformin has been used for alleviating metabolic abnormalities in patients with schizophrenia. Until now, the lowest dose of metformin to treat metabolic abnormalities in clozapine-treated patients is 1000 mg/d. The aim of this study was to determine whether a lower dosage of metformin, such as 500 mg/d, is effective for improving metabolic profiles in clozapine-treated patients with pre-existing metabolic abnormalities.
Methods:
In this 12-week, randomized, double-blind, placebo-controlled trial, metformin 500 mg/d or 1000 mg/d or a placebo was prescribed to clozapine-treated patients with schizophrenia having pre-existing metabolic abnormalities. The recruited patients underwent physical and laboratory evaluations at week-4, week-8, and week-12.
Who can participate
Age range20 Years – 65 Years
SexALL
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Inclusion criteria
✓. patients diagnosed with schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition
✓. aged 20-65 years
✓. had taken clozapine for at least 3 months
✓. had at least one of the following metabolic abnormalities: BMI ≥ 24; WC \> 90 cm (men) or 80 cm (women); fasting serum TG level ≥ 150 mg/dL; fasting serum HDL-C level ≤ 40 mg/dL (men) or 50 mg/dL (women); systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg; current use of antihypertensive agents; and FPG level = 100-126 mg/dL.
Exclusion criteria
✕. history of diabetes mellitus
✕. current use of hypoglycemic or hypolipidemic agents