Overview

Adjunctive Low-dose Metformin in Patients With Schizophrenia and Metabolic Abnormalities

Status:
Completed

Trial end date:
2015-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Taipei Medical University WanFang Hospital

Collaborator:

Taipei City Hospital

Treatments:

Clozapine
Metformin

Criteria

Inclusion Criteria:

1. patients diagnosed with schizophrenia or schizoaffective disorder according to the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition

2. aged 20-65 years

3. had taken clozapine for at least 3 months

4. 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:

1. history of diabetes mellitus

2. current use of hypoglycemic or hypolipidemic agents

3. pregnancy

4. allergy to metformin

5. a creatinine level > 1.4 ng/dL

6. an abnormal liver function test result

7. chronic cardiopulmonary insufficiency.