Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-24 @ 11:46 PM
NCT ID:
NCT03414151
Eligibility Criteria:
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
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
35 Years
Study:
NCT03414151
Study Brief:
Protocol Section:
NCT03414151