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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07483294
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a first-episode psychotic disorder including: schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, psychotic disorder NOS, bipolar disorder with psychosis, and major depressive disorder with psychosis;
* Current positive symptoms rated \> 3 (moderate) on one or more of the BPRS psychosis items: conceptual disorganization, grandiosity, hallucinatory behavior, and unusual thought content;
* At early phase of illness as defined by having taken antipsychotic drugs for a cumulative lifetime period of 8 weeks or less;
* Age 16 to 40;
* Competent to sign informed consent.
Exclusion Criteria:
* Serious neurological or endocrine disorder or brain trauma;
* Any medical condition which requires treatment with a medication with psychotropic effects;
* Significant risk of suicidal or homicidal behavior;
* Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent;
* Contraindications to antipsychotic monotherapy;
* Contraindications to MR imaging (e.g. pacemaker);
* Pregnancy by self report.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
40 Years
Study:
NCT07483294
Study Brief:
Protocol Section:
NCT07483294