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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT02751632
Eligibility Criteria:
INCLUSION CRITERIA
* Age 12 -25 years (inclusive) at entry.
* Ability to speak adequate English (for assessment purposes).
* Ability to provide informed consent.
* Meeting one or more Ultra High Risk for psychosis groups as defined below:
Group 1: Vulnerability Group
Family history of psychosis in first degree relative OR Schizotypal Personality Disorder (as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV in identified patient
AND
Drop in Functioning:
Recency: Change in functioning occurred within last year Impact: Social and Occupational Functioning Assessment Scale (SOFAS) score at least 30% below previous level of functioning and sustained for at least one month.
OR
Sustained low functioning:
Recency: For the past 12 months or longer Impact: SOFAS score of 50 or less.
Group 2: Attenuated Psychotic Symptoms Group 2a) Subthreshold intensity:
Intensity: Global Rating Scale Score of 3-5 on Unusual Thought Content subscale, 3-5 on Non-Bizarre Ideas subscale, 3-4 on Perceptual Abnormalities subscale and/or 4-5 on Disorganised Speech subscales of the Comprehensive Assessment of At Risk Mental States (CAARMS).
Frequency: Frequency Scale Score of 3-6 on Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS
Duration: symptoms present for at least one week
Recency: symptoms present in past year
2b) Subthreshold frequency:
Intensity: Global Rating Scale Score of 6 on Unusual Thought Content subscale, 6 on Non-Bizarre Ideas subscale, 5-6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS
Frequency: Frequency Scale Score of 3 on Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS
Recency: symptoms present in past year
Group 3: Brief Limited Intermittent Psychotic Symptoms Intensity: Global Rating Scale Score of 6 on Unusual Thought Content subscale, 6 on Non-Bizarre Ideas subscale, 5 or 6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS
Frequency: Frequency Scale Score of 4-6 on Unusual Thought Content, Non-Bizarre Ideas, Perceptual Abnormalities and/or Disorganised Speech subscales
Duration: Symptoms present for less than one week and spontaneously remit on every occasion.
Recency: symptoms present in past year
EXCLUSION CRITERIA
* Past history of a psychotic episode of one week or longer, whether treated with antipsychotic medications or not.
* Attenuated psychotic symptoms only present during acute intoxication.
* Organic brain disease known to cause psychotic symptoms, e.g. temporal lobe epilepsy.
* Any metabolic, endocrine or other physical illness, e.g. thyroid disease, with known neuropsychiatric consequences.
* Diagnosis of a serious developmental disorder, e.g. Severe Autism Spectrum Disorder.
* Premorbid Intelligence Quotient (IQ) \<70 and a documented history of developmental delay or intellectual disability.
* Current or previous SCID diagnosis of Bipolar I.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
25 Years
Study:
NCT02751632
Study Brief:
Protocol Section:
NCT02751632