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ACTIVE NOT RECRUITING
NCT03414151

Gut Microbiome in AP Naive

Sponsor: Centre for Addiction and Mental Health

View on ClinicalTrials.gov

Summary

Antipsychotic (AP) medications are currently the cornerstone of treatment for schizophrenia (SCZ), with off-label prescription rapidly increasing in youth, with an established two-fold increase in standardized mortality ratio attributable to cardiovascular disease in this population. However, APs have been associated with common and serious metabolic adverse effects including weight gain and diabetes, to which youth are disproportionally vulnerable. The Gut Microbiome (GMB) has been suggested as a potential target warranting further study as a mechanism of AP induced weight gain and has also been linked directly with cognition and behavior. It is hypothesized that there will be changes in the gut microbiome overtime with treatment correlated with metabolic measures and that APs will produce changes in glucose tolerance, insulin sensitivity, adipokines, glucagon like peptide (GLP)-1, lipids, fasting glucose, body weight, and cognition.

Official title: Gut Microbiome and Metabolic Dysfunction in Antipsychotic Naïve Patients

Key Details

Gender

All

Age Range

12 Years - 35 Years

Study Type

OBSERVATIONAL

Enrollment

25

Start Date

2018-02-07

Completion Date

2026-08

Last Updated

2026-05-27

Healthy Volunteers

Not specified

Interventions

OTHER

Observation

No intervention administered.

Locations (1)

Centre For Addiction and Mental Health

Toronto, Ontario, Canada