The Staged Treatment in Early Psychosis Study (NCT02751632) | Clinical Trial Compass
CompletedPhase 3
The Staged Treatment in Early Psychosis Study
Australia342 participantsStarted 2016-04
Plain-language summary
A sequential multistage randomised clinical trial (SMART) to produce evidence to guide a step-wise clinical approach for the treatment of ultra high risk patients and reduction of risk for psychosis and other deleterious clinical and/or functional outcomes.
Who can participate
Age range12 Years – 25 Years
SexALL
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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 Tho…