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Gut Microbiome in AP Naive

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Editor's note
Antipsychotic-induced metabolic dysfunction—weight gain and diabetes—remains a major barrier to treatment adherence in youth with schizophrenia, yet the biological mechanism remains opaque. This longitudinal RCT directly tests whether dysbiotic shifts in gut bacterial composition drive these effects, bridging colonization dynamics with clinically measurable metabolic and cognitive outcomes. Psychiatrists, endocrinologists, and microbiome researchers investigating drug-microbiome interactions will find this mechanistic evidence particularly relevant as it could reshape how we prevent or mitigate a leading cause of treatment dropout.

Source: ctgov · Centre for Addiction and Mental Health · ACTIVE_NOT_RECRUITING · 2026-05-27

URL: https://clinicaltrials.gov/study/NCT03414151

AI rationale (4/5, tier: emerging): Longitudinal RCT of microbiome-targeted mechanism (AP-induced dysbiosis→metabolic dysfunction); matches INCLUDE criteria for colonisation dynamics and mechanistic cohort work.

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.

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Published 2026-05-28 · Last kit-update 2026-05-28