Gut Microbiome in AP Naive
Palo Alto (17 mi)Overseen byMargaret K Hahn, PhD, MD
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: Centre for Addiction and Mental Health
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
Treatment Details
2Treatment groups
Experimental Treatment
Group I: Observational - Healthy Control ArmExperimental Treatment1 Intervention
All participants will be placed in this arm if they are healthy controls (there is no randomization procedure)
Group II: Observational - Case ArmExperimental Treatment1 Intervention
All participants will be placed in this arm or group if they have an eligible psychiatric diagnosis as a case (there is no randomization procedure)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Centre For Addiction and Mental HealthToronto, Canada
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Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
McMaster UniversityCollaborator