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
Sex
ALL
Min age
12 Years
Max age
35 Years
Healthy volunteers
No
Inclusion Criteria:
* Ages 12-35
* Antipsychotic naïve or antipsychotic treatment for equal to or less than 2 weeks within the past 3 months; the minimum AP dose will be left to the discretion of the PI
* DSM-5 diagnosis (using SCID-IV-TR with supplemental questions from SCID-5 or SCID-5) of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, and brief psychotic disorder, psychotic disorder NOS. and/or antipsychotic treatment for schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum and other psychotic disorder.
Exclusion Criteria:
* Previous antipsychotic treatment (greater than two weeks within the preceding 3 months)
* Presence of DSM-5 diagnosis which is not schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum and other psychotic disorder
* Use of any other medications for treatment of lipids, glucose, or weight as deemed to be clinically significant by the PI
* Use of other medications where the dose has changed within the past 6 weeks which are deemed by the PI to be clinically significant
* Pregnancy
* Eating disorder - active or previous
* Major medical or surgical event within the preceding 3 months
* Acute suicidal risk
* Irritable bowel disease, Crohn's disease, and/or diverticulitis/diverticulosis
* Type I diabetes, kidney/liver disease, and/or cancer
* Organ transplant
* Moderate to severe alcohol use , use of street drugs, and/or cannabis use (as deemed by PI)
* Immunosuppressants and/or anti-inflammatory medications
* Antibiotic/probiotic use within past 4 weeks
* Any other medical conditions or lifestyle habits deemed by the PI to impact the integrity of the sample/microbiota
Primary outcome measure(s)
Change in Gut microbiome and DNA — 12 weeks (baseline, week 6, week 12) Patients will collect fecal samples at home using our well-established protocol at baseline, 6 weeks, and 12 weeks. Participants will be provided a kit containing a sterile specimen container and a cooling pad, as well as a stool collection tube for DNA analyses (OMNIgene•GUT, DNA Genotek Ottawa, ON). Patients will be instructed to transfer several grams of the feces into the specimen container and place the sample in the 2 bioharzard bags and then store in the freezer. On the day of their appointment they will transport the sample on the cooling pad (previously placed in the freezer) to their appointment. When the patient delivers the sample to the research staff, it will be immediately placed in a -80ºC freezer prior to being analyzed. These analyses with fecal samples will be conducted at McMaster University at the Farncombe Family Institute.
Trial sites (1)
Facility
City
Region
Status
Centre For Addiction and Mental Health
Toronto
Ontario
More Centre for Addiction and Mental Health trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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