Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders
Trial ID: NCT05813080
Status: ACTIVE_NOT_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-05-01
Completion date: 2026-03
Sponsor: Heinrich-Heine University, Duesseldorf
Conditions: Psychotic Disorders; Prevention
Interventions: "pronia.ai" medical device for high risk psychosis prognosis; Treatment-as-usual (TAU)
Locations: ZfP Reichenau - Akademisches Lehrkrankenhaus Universität Konstanz; Zentralinstitut für Seelische Gesundheit; Klinik für Psychiatrie und Psychotherapie Universität Tübingen; Bezirkskrankenhaus Augsburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Universität Augsburg; Klinikum der Ludwig-Maximilians-Universität München; Zentrum für psychische Gesundheit, U11iversitätsklinikum Würzburg; Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Universitätsklinikum Aachen, RWTH Universität Aachen; LWL-Universitätsklinikum Bochum der Ruhr--Universität Bochum, Klinik für Psychiatrie, Psychotherapie und Präventivmedizin; KJPP LVR-Klinik Bonn; Universitätsklinikum Bonn Klinik für Psychiatrie und Psychotherapie; Uniklinik Köln, Klinik und Poliklin-ik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters; Klinik und Poliklinik für Psychiatrie und Psychotherapie Heinrich-Heine-Universität Düsseldorf; Institut für Translationale Psychiatrie; Rheinhessen Fachklinik Alzey; UKD Dresden, Klinik und Poliklinik für Psychiatrie und Psychotherapie; Otto-von-Guericke- Universität Magdeburg; Zentrum für Integrative Psychiatrie Kiel; Zentrum für Integrative Psychiatrie (ZIP) und Fachklinik für Junges Leben (JuLe) Kinder- und Jugendpsychiatrie; Vivantes Klinikum Am Urban; Charité - Universitätsmedizin Berlin; Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf {UKE)
Countries: Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany; Germany
Enrollment: 260
Age range: 16 Years - 40 Years
Sex: ALL

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 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

Outcomes:
Structured Interview for Psychosis-Risk Syndromes (SIPS)