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

NCT02751307 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2016-04-28

No results posted yet for this study

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.

Conditions

  • Metabolic Syndrome

Interventions

DRUG

metformin 500 mg

metformin 500 mg QAM for metformin 500 mg/d group; metformin 500 mg 1 BID for metformin 1000 mg/d

DRUG

clozapine 100 mg

Clozapine dose remained unchanged during metformin intervention period in recruited patients.

Sponsors & Collaborators

  • Taipei City Hospital

    collaborator OTHER_GOV

  • Taipei Medical University WanFang Hospital

    lead OTHER

Principal Investigators

  • Chun-Hsin Chen, MD · Department of Psychiatry, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-01-31
Completion
2015-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02751307 on ClinicalTrials.gov