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AI could spot psychosis risk before it strikes

NCT ID NCT05813080

Prevention Sponsor: Heinrich-Heine University, Duesseldorf Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a computer program called pronia.ai can help doctors identify young people at high risk for psychosis and offer them early, tailored treatment. Participants aged 16 to 40 with early warning signs will either receive standard care or the AI-guided approach, which includes extra testing and up to 24 therapy sessions. The goal is to see if this method can prevent the first episode of psychosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pronia.ai medical device
What this could lead to
If successful, this approach could enable earlier, more personalized care to prevent the onset of psychotic disorders in at-risk individuals.
What could go wrong
The AI tool is still experimental, and its accuracy in real-world settings is unproven. The trial is relatively small, and results may not apply to all populations.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

260 people

The number who actually took part.

Started

May 2023

Finished

Dec 2025

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

16 to 40 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: * The increased risk of psychosis includes either a symptomatic "ultra high-risk" stage of the Structured Interview for Psychosis-Risk Syndromes or the "Cognitive Disturbances" risk criterion of the Schizophrenia Proneness Instrument - Children and Youth and Adult versions * ages 16 to 40 * Presence of a written informed consent from the patient and, if applicable, the legal guardian. Exclusion Criteria: * manifest psychosis according to the definition of the Structured Interview for Psychosis-Risk Syndromes (according to the PRONIA-study) (At least one P-syndrome with a rating of 6 on a daily frequency and for a period of more than one week) * Lack of capacity to give consent (the patient lacks the capacity to consent if the individual case with regard to the specific treatment measure is excluded. Only when the physician has concrete indications that the patient's capacity to consent may be lacking, he may and must must examine it. Mental disorders (e.g. delirium, dementia, psychosis, mania, depression) or cognitive impairments can have an influence on the capacity to consent. Indications for doubts of a ability to give informed consent exist if the physician has the impression that the patient is not able to understand the provided patient information and is not able to reproduce essential information about the study in his or her own words and is not aware of the possible consequences of the proposed measures * Severe suicidality during the recruitment phase (CDSS items 8 ≥2) * A current or past neurological disease of the brain. * a current or past known somatic disease that potentially affects the structure or function of the brain * Antipsychotic medication in the indication treatment of psychotic symptoms for \>30 days (cumulative number of days) at or above the starting dose for psychosis according to the current German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) S3 guidelines. * an antipsychotic medication in the indication treatment of psychotic symptoms in the 3 months prior to the initial examination (regardless of the duration of use) at or above the starting dose for psychosis according to the current DGPPN S3 guidelines * An inadequate level of hearing for neurocognitive testing * a current or past head trauma with unconsciousness (\>5 min). * a current or past alcohol dependence (ICD-10 F10.x) * A current polytoxicomania (multiple substance dependence) or polytoxicomania in the past 6 months (ICD-10 F19.x) * Presence of medical reasons that contraindicate performance of an MRI * Insufficient language skills to understand the indication and the purpose of the intended examinations and interventions * stationary accommodation against the patient's will

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Conditions

The condition(s) this trial relates to.

Cognition Disorders Psychotic Disorders psychotic disorder prevention target

As listed by the trial registrant

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

Prevention Psychotic disorders

Contacts and locations

Locations

  • Bezirkskrankenhaus Augsburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Universität Augsburg

    Augsburg, Bavaria, 86156, Germany

  • Charité - Universitätsmedizin Berlin

    Berlin, State of Berlin, 13353, Germany

  • Institut für Translationale Psychiatrie

    Münster, North Rhine-Westphalia, 48149, Germany

  • KJPP LVR-Klinik Bonn

    Bonn, North Rhine-Westphalia, 53111, Germany

  • Klinik für Psychiatrie und Psychotherapie Universität Tübingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Universitätsklinikum Aachen, RWTH Universität Aachen

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Klinik und Poliklinik für Psychiatrie und Psychotherapie Heinrich-Heine-Universität Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40629, Germany

  • Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf {UKE)

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • Klinikum der Ludwig-Maximilians-Universität München

    München, Bavaria, 80336, Germany

  • LWL-Universitätsklinikum Bochum der Ruhr--Universität Bochum, Klinik für Psychiatrie, Psychotherapie und Präventivmedizin

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Otto-von-Guericke- Universität Magdeburg

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • Rheinhessen Fachklinik Alzey

    Alzey, Rhineland-Palatinate, 55232, Germany

  • UKD Dresden, Klinik und Poliklinik für Psychiatrie und Psychotherapie

    Dresden, Saxony, 01307, Germany

  • Uniklinik Köln, Klinik und Poliklin-ik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters

    Cologne, North Rhine-Westphalia, 50931, Germany

  • Universitätsklinikum Bonn Klinik für Psychiatrie und Psychotherapie

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Vivantes Klinikum Am Urban

    Berlin, State of Berlin, 10967, Germany

  • Zentralinstitut für Seelische Gesundheit

    Mannheim, Baden-Wurttemberg, 68159, Germany

  • Zentrum für Integrative Psychiatrie (ZIP) und Fachklinik für Junges Leben (JuLe) Kinder- und Jugendpsychiatrie

    Lübeck, Schleswig-Holstein, 23554, Germany

  • Zentrum für Integrative Psychiatrie Kiel

    Kiel, Schleswig-Holstein, 24105, Germany

  • Zentrum für psychische Gesundheit, U11iversitätsklinikum Würzburg

    Würzburg, Bavaria, 97080, Germany

  • ZfP Reichenau - Akademisches Lehrkrankenhaus Universität Konstanz

    Konstanz, Baden-Wurttemberg, 78479, Germany

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