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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT05601050
Eligibility Criteria:
Inclusion Criteria:
* Speaks English with conversational proficiency
* Current DSM-V-defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, unspecified psychotic disorder, or brief psychotic disorder or bipolar 1 disorder with psychotic features or major depressive disorder with psychotic features using the Structured Clinical Interview for Axis I DSM-V Disorders (SCID-I/P).
* Current significant positive or disorganized symptoms of psychosis (DSM 5 Criterion A) including rating at or above any of the following on the BPRS:
* Grandiosity (Severe - 6)
* Suspiciousness (Moderately Severe - 5)
* Hallucinations (Moderately Severe - 5)
* Unusual thought content (Moderate - 4)
* Bizarre Behavior (Moderate - 4)
* Disorientation (Moderate - 4)
* Conceptual Disorganization (Moderate - 4)
* Early phase of psychotic illness as defined by less than 2 years elapsed since reaching threshold for psychotic disorder
* Age 15 to 40 years
* Has capacity and willing to sign informed consent; if minor, parent is willing to give consent and child is willing to give assent.
* Screening will not include a pregnancy test. Pregnant women will not be screened out of the study because the study procedures are of very low risk overall, and pregnancy does not place the participant or the fetus at any significant risk.
* Minors will be included in the study because psychosis symptoms frequently onset before the age of 18 and this patient group is particularly in need of accurate prognosis and treatment. Therefore, it is of vital importance that the conclusions of the study be applicable to minors and that they be included among the participants.
Exclusion Criteria:
* Participants with substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, or shared psychotic disorder will not be included.
* Patient currently under the influence of alcohol or drugs.
* Disorders affecting speech or language, such as aphasia, intellectual disability (IQ\<70), or language disorder, or movement disorders affecting speech like tardive dyskinesia, or physical impairments causing significant distortions to speech
* Serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain and/or language, including but not limited to: neurodegenerative disorders, traumatic brain injury with active symptoms, autism spectrum disorder, encephalitis, epilepsy
* Significant risk of suicidal or homicidal behavior;
* Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
40 Years
Study:
NCT05601050
Study Brief:
Protocol Section:
NCT05601050