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Metformin in Co-morbid Diabetes or Prediabetes and Serious Mental Illness

NCT02167620 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2018-07-30

No results posted yet for this study

Summary

Schizophrenia is associated with a lifespan shortened by 20 years, due to cardiovascular disease (CVD), with antipsychotic (AP) medications understood to contribute to this risk through associated metabolic side-effects. Metformin, a medication used to treat prediabetes, and diabetes in the general population, holds promise with regard to reduction of AP-related metabolic problems, but has not been directly tested in early episode patients beyond weight loss, nor specifically in patients with diabetes or prediabetes and psychosis. We propose to replicate findings that metformin can reduce weight gain, and dysglycemia uniquely focusing on an early episode population diagnosed with prediabetes or diabetes. To help determine long-term risk/benefit of adjunctive metformin, we propose to look at changes in abdominal and liver fat, two well-established risk factors for CVD. Given links between dysglycemia, obesity with hippocampal volume loss and cognitive dysfunction, we will explore if improvements in metabolic indices are associated in changes in cognition and brain structure.

Conditions

Interventions

DRUG

Metformin

Metformin will be dispensed on a biweekly basis, and pill counts conducted at each visit.

DRUG

Placebo

Placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.

Sponsors & Collaborators

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Margaret Hahn · Center for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2018-02-28
Completion
2018-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02167620 on ClinicalTrials.gov