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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT05905003
Eligibility Criteria:
Inclusion Criteria:
* Individuals between 12 and 30 years old;
* Understand and sign an informed consent (or assent for minors) document;
* Meet diagnostic criteria for CHR from the Positive SYmptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS (PSYCHS).
Exclusion Criteria:
* Antipsychotic medication exposure equivalent to a total lifetime haloperidol dose of \>50 mg or current antipsychotic medication at time of screening assessment;
* Documented history of intellectual disability;
* Past or current clinically relevant central nervous system disorder;
* Traumatic brain injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument;
* Current or past treated or untreated psychotic episode, as determined using the PSYCHS.
See also the AMP SCZ website link for a description of eligibility criteria (https://www.ampscz.org/participate/eligible/).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
30 Years
Study:
NCT05905003
Study Brief:
Protocol Section:
NCT05905003