Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
77 participants
OBSERVATIONAL
2021-03-04
2023-03-01
Brief Summary
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Detailed Description
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The investigators will test whether these features meaningfully reflect clinical symptoms, cognition, and functioning, and whether they help predict how psychosis symptoms change over time.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PSD (Psychosis spectrum disorder) group
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).
There is no intervention
There is no intervention
Interventions
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There is no intervention
There is no intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
40 Years
ALL
No
Sponsors
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Winterlight Labs
INDUSTRY
Northwell Health
OTHER
Responsible Party
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Sunny Tang
Assistant Professor
Principal Investigators
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Sunny X Tang, MD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health, The Feinstein Institutes of Medical Research
Locations
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Zucker Hillside Hospital
Glen Oaks, New York, United States
Countries
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Other Identifiers
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20-0460
Identifier Type: -
Identifier Source: org_study_id
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