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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT05890768
Eligibility Criteria:
Patient group:
* Inclusion:
1. Diagnosis of DSM-5 schizophrenia, bipolar-I mania and mixed episodes with psychotic features, schizophreniform, schizoaffective, delusional, and unspecified schizophrenia spectrum and other psychotic disorders, established with SCID-P for DSM-5;
2. age between 18 and 40 years old;
3. antipsychotic exposure no greater than 50 mg of olanzapine equivalents (Gardner et al. AJP, 2010) in the 7 days previous to baseline assessments.
* Exclusion:
1. neurological disorder, intellectual disability, history of severe head trauma (unconciousness \>10 min);
2. diagnosis of active substance use disorder (except for nicotine and cannabinoids \[cannabinoids use is a risk factor for psychosis\]).
Healthy Volunteers (HV) group:
* Inclusion:
a) age between 18 and 40 years old.
* Exclusion:
1. current or past psychiatric disorder (assessed with the SCID-NP; subjects with past history of anxiety or depressive disorders receiving no active treatment in the previous 12 months may be included);
2. past or current diagnosis of neurological disorder, history of severe head trauma or diagnosis of active substance use disorder (except for nicotine or cannabinoids); and c) history of a psychotic disorder in first-degree relatives.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05890768
Study Brief:
Protocol Section:
NCT05890768