The Staged Treatment in Early Psychosis Study

• Status: Active, not recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orygen; Orygen Youth Health Research Centre
• Collaborators: National Institute of Mental Health (NIMH); University of California, Davis; University of California, San Francisco
• Treatments: Fluoxetine

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.