Status:
UNKNOWN
Gut Microbiome in AP Naive
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
McMaster University
Conditions:
Psychotic Disorder
Schizophrenia
Eligibility:
All Genders
12-35 years
Brief 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 sta...
Detailed Description
The objectives of the study are to examine the gut microbiome composition and diversity in patients with schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum and other ps...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 7 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03414151
Start Date
February 7 2018
End Date
March 1 2022
Last Update
July 26 2021
Active Locations (1)
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1
Centre For Addiction and Mental Health
Toronto, Ontario, Canada, M5T1R8