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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT06155695
Eligibility Criteria:
Inclusion Criteria:
* Between the ages of 18-40
* Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Psychosis not otherwise specified (NOS), Affective Psychosis with mood incongruent hallucinations.
* ability to provide informed consent
* Intelligence quotient (IQ) \>= 70, as measured by the Weschler Abbreviated Scale of Intelligence (WASI)
* \<5 years since the onset of first psychotic episode
* persistent auditory hallucinations without remission despite attempting \>2 antipsychotic medications and having \> 1 month of medication compliance
Exclusion Criteria:
* hearing deficit as assessed by audiometry (hearing threshold \> 30 decibels (dB) nHL)
* standard MRI contraindications (e.g. cardiac pacemaker, aneurysm clip, cochlear implants, history of metal fragments in body, neurostimulators, weight of 300 lbs. or more, or claustrophobia)
* \[self report\] head injury with loss of conscious \> 10 min, medical illness affecting brain function or structure, significant neurologic disorder (e.g. seizure disorder),
* Diagnostic and Statistical Manual of Mental Disorders (DSM-5) substance use disorder - other than cannabis - and except individuals who have met at least early remission criteria (3 months without dependence symptoms) or a psychotic illness with a temporal relation to a substance use disorder
* currently pregnant or early postpartum (\<6 weeks after delivery or miscarriage)
* currently taking medications that affect alertness, other than antipsychotic medication (e.g. sedatives, tranquilizers, muscle relaxants, and sleeping aids)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06155695
Study Brief:
Protocol Section:
NCT06155695