Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders

Last updated: March 14, 2025
Sponsor: Heinrich-Heine University, Duesseldorf
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Schizophrenia And Schizoaffective Disorders (Pediatric)

Schizotypal Personality Disorder (Spd)

Treatment

Treatment-as-usual (TAU)

"pronia.ai" medical device for high risk psychosis prognosis

Clinical Study ID

NCT05813080
HeinrichHeine
  • Ages 16-40
  • All Genders

Study Summary

Multicenter randomized controlled trial (RCT) with artificial intelligence (AI)-staged early diagnostics and risk-adapted treatment (RAB) as interventional treatment arm and treatment-as-usual (TAU) as control treatment arm for patients with an increased clinical risk for psychosis.

Eligibility Criteria

Inclusion

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 "CognitiveDisturbances" risk criterion of the Schizophrenia Proneness Instrument - Childrenand Youth and Adult versions

  • ages 16 to 40

  • Presence of a written informed consent from the patient and, if applicable, thelegal guardian.

Exclusion

Exclusion Criteria:

  • manifest psychosis according to the definition of the Structured Interview forPsychosis-Risk Syndromes (according to the PRONIA-study) (At least one P-syndromewith 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 theindividual case with regard to the specific treatment measure is excluded. Only whenthe physician has concrete indications that the patient's capacity to consent may belacking, he may and must must examine it. Mental disorders (e.g. delirium, dementia,psychosis, mania, depression) or cognitive impairments can have an influence on thecapacity to consent. Indications for doubts of a ability to give informed consentexist if the physician has the impression that the patient is not able to understandthe provided patient information and is not able to reproduce essential informationabout the study in his or her own words and is not aware of the possibleconsequences 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 orfunction of the brain

  • Antipsychotic medication in the indication treatment of psychotic symptoms for >30days (cumulative number of days) at or above the starting dose for psychosisaccording to the current German Association for Psychiatry, Psychotherapy andPsychosomatics (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 orabove 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 thepast 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 theintended examinations and interventions

  • stationary accommodation against the patient's will

Study Design

Total Participants: 260
Treatment Group(s): 2
Primary Treatment: Treatment-as-usual (TAU)
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
March 31, 2026

Study Description

The study is a Investigator Initiated Trial (IIT)/Other clinical trial of a class 2a medical device according to article 82 medical devices regulation of the European Union.

The aim of risk-adapted treatment (RAB) arm is to reduce the number of patients with an increased clinical risk for psychosis to actually develop a manifest psychosis.

Patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing.

The AI-supported algorithm "pronia.ai" uses information from both the individual patient data of the specialized routine diagnostics as well as from in-depth clinical diagnostics.

There are two predictions, an individual quantitative assessment of the individual risk of transition to psychosis and the individual prognosis with regard to the level of psychosocial functioning 12 months after inclusion in the study.

The therapists and patients receive a non-binding risk profile from the AI-based recommendation to adjust the treatment intensity from 16 to 24 sessions over a period of six months.

The cognitive behavioral therapy-based manual "Integrated Preventive Psychological Preventive Psychological Intervention (IPPI)" manual is used. In the treatment-as-usual arm (TAU),the patients receive referral back to the previous care system; further treatment (and additional diagnostics, if necessary) is left to the referring primary care providers.

Connect with a study center

  • ZfP Reichenau - Akademisches Lehrkrankenhaus Universität Konstanz

    Konstanz, Baden-Württemberg 78479
    Germany

    Site Not Available

  • Zentralinstitut für Seelische Gesundheit

    Mannheim, Baden-Württemberg 68159
    Germany

    Site Not Available

  • Klinik für Psychiatrie und Psychotherapie Universität Tübingen

    Tübingen, Baden-Württemberg 72076
    Germany

    Site Not Available

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

    Augsburg, Bavaria 86156
    Germany

    Site Not Available

  • Klinikum der Ludwig-Maximilians-Universität München

    München, Bayern 80336
    Germany

    Site Not Available

  • Zentrum für psychische Gesundheit, U11iversitätsklinikum Würzburg

    Würzburg, Bayern 97080
    Germany

    Site Not Available

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

    Aachen, NRW 52074
    Germany

    Site Not Available

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

    Bochum, NRW 44791
    Germany

    Site Not Available

  • KJPP LVR-Klinik Bon'n

    Bonn, NRW 53111
    Germany

    Active - Recruiting

  • KJPP LVR-Klinik Bonn

    Bonn, NRW 53111
    Germany

    Site Not Available

  • Universitätsklinikum Bonn Klinik für Psychiatrie und Psychotherapie

    Bonn, NRW 53127
    Germany

    Site Not Available

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

    Düsseldorf, NRW 40629
    Germany

    Site Not Available

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

    Köln, NRW 50931
    Germany

    Site Not Available

  • Institut für Translationale Psychiatrie

    Münster, NRW 48149
    Germany

    Site Not Available

  • Rheinhessen Fachklinik Alzey

    Alzey, Rheinland-Pfalz 55232
    Germany

    Site Not Available

  • UKD Dresden, Klinik und Poliklinik für Psychiatrie und Psychotherapie

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • Otto-von-Guericke- Universität Magdeburg

    Magdeburg, Sachsen-Anhalt 39120
    Germany

    Site Not Available

  • Zentrum für Integrative Psychiatrie Kiel

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

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

    Lübeck, Schleswig-Holstein 23554
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353
    Germany

    Site Not Available

  • Vivantes Klinikum Am Urban

    Berlin, 10967
    Germany

    Site Not Available

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

    Hamburg, 20246
    Germany

    Site Not Available

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