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 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT05142735
Eligibility Criteria:
Inclusion Criteria:
1. meeting Criteria of Psychosis-Risk Syndromes (COPS) criteria on the Structured Interview for Psychosis-Risk Syndromes (SIPS)
2. capacity to provide informed consent
3. if female, participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure or have been post-menopausal for at least 1 year prior to screening OR participant is of child-bearing potential and agrees to use a medically approved method of birth control for the duration of the study
Exclusion Criteria:
1. meeting criteria for any other DSM-5 diagnosis at the time of the study (except -personality disorder, nicotine use disorder, or other substance use disorder in full remission)
2. concomitant or past neurological condition
3. visual impairment which is not corrected to normal by prescription glasses history of reading disability
4. past antipsychotic treatment at a therapeutic dose
5. current treatment with a psychotropic medication except antidepressants on which the participants has been on a stable dose for at least 30 days.
6. pregnancy (as identified on self-report and/or rapid urine pregnancy test) or intent to become pregnant according to self-report
7. breastfeeding or plan to do so
8. history of kidney stones
9. current treatment with an antibiotic
10. current treatment with nitroglycerin
11. allergy to any ingredients in either the investigational product or placebo product
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
35 Years
Study:
NCT05142735
Study Brief:
Protocol Section:
NCT05142735