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 @ 10:00 PM
Ignite Modification Date:
2025-12-24 @ 10:00 PM
NCT ID:
NCT02567032
Eligibility Criteria:
Inclusion Criteria for Patients:
* 18 to 45 years of age
* Clinically stable
* English Speaking
* Meet DSM-5 criteria for schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder with psychotic features, or brief psychotic disorder
* No or at most only minor changes to medications in the past week
* Able to use nasal spray
* Must be capable of providing informed consent
Inclusion Criteria for healthy volunteers:
* 18 to 45 years of age
* Clinically stable
* English Speaking
* No diagnosis of mental disorder according to DSM-5, not including mild alcohol use disorder or mild cannabis use disorder
* Able to use nasal spray
* Must be capable of providing informed consent
Exclusion Criteria for Patients:
* Active substance and alcohol use disorder in the past month as determined by the DSM-5 criteria, not including cannabis use disorder
* Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
* Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
* Hearing deficits
* Pregnancy
* Severe brain trauma
Exclusion Criteria for Healthy Controls:
* Active substance and moderate/severe alcohol use disorder, or mood disorder in the past month as determined by the DSM-5 criteria, not including mild alcohol use disorder or mild cannabis use disorder
* Meet for a current psychiatric disorder according to DSM-5 criteria
* Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
* Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
* Hearing deficits
* Pregnancy
* Severe brain trauma
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02567032
Study Brief:
Protocol Section:
NCT02567032