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New staged treatment shows promise for preventing psychosis in At-Risk youth

NCT ID NCT02751632

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a step-by-step treatment approach for 342 young people aged 12-25 who are at ultra high risk of developing psychosis. The goal was to see if a sequence of therapies and medications could improve daily functioning and reduce the chance of psychosis. The approach uses a staged plan, starting with one treatment and adding others if needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

342 people

The number who actually took part.

Started

Apr 2016

Finished

May 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 25 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

personality disorder Personality Disorders Psychotic Disorders psychotic disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Headspace

    Craigieburn, Victoria, 3064, Australia

  • Headspace

    Glenroy, Victoria, 3046, Australia

  • Headspace

    Sunshine, Victoria, 3020, Australia

  • Headspace

    Werribee, Victoria, 3030, Australia

  • Orygen Youth Health Clinical Program

    Melbourne, Victoria, 3052, Australia

More trials for these conditions

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