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 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT07226895
Eligibility Criteria:
Inclusion Criteria:
* Aged 17 to 30 years at time of consent.
* Capacity to provide informed consent. (For patients under 17 years, participants must assent and informed consent provided by one parent or legal guardian).
* Meet diagnostic criteria for Clinical High Risk of Psychosis (CHR).
* For females of reproductive potential - not pregnant or nursing and willing to comply with contraceptive requirements.
Exclusion Criteria:
* Clinically significant medical disorder or laboratory test abnormality at Day 1.
* History of or current condition which may prevent participant from complying with study procedures.
* Past or current schizophrenia, other disorder with symptoms of psychosis, major cognitive disorder resulting from traumatic brain injury.
* Received antipsychotic medication equivalent to a total lifetime haloperidol dose \>50 mg.
* Current use of medications which could interfere with the study endpoints - to be assessed by the Investigator at screening.
* Unable to abstain from nicotine (e.g. cigarettes, vape) for two hours before cognitive testing.
* Unable to abstain from marijuana use on test day prior to test completion.
* History of suicide attempt or behavior in previous 12 months, or risk of suicidal behavior during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Maximum Age:
30 Years
Study:
NCT07226895
Study Brief:
Protocol Section:
NCT07226895