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NCT05813080Completed

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

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
260 (actual)
First submitted
14 Mar 2023
Start date
1 May 2023
Primary completion date
16 Dec 2025
Lead sponsor
Heinrich-Heine University, Duesseldorf
NCT number
NCT05813080

What you commit to

  • Study type: Interventional
  • Participants enrolled: 260
  • From 1 May 2023 to the primary completion date, 16 Dec 2025
  • 21 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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
  • 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

Other

  • Severe suicidality during the recruitment phase (CDSS items 8 ≥2)
  • 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

Who the study is looking for

  • 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.

Age in the registry: 16 years to 40 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Klinik für Psychiatrie, Psychotherapie und Psychosomatik, Universitätsklinikum Aachen, RWTH Universität Aachen
Coordinator of this site? Confirm its status
AachenGermanyUnknown status
Rheinhessen Fachklinik Alzey
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AlzeyGermanyUnknown status
Bezirkskrankenhaus Augsburg, Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Universität Augsburg
Coordinator of this site? Confirm its status
AugsburgGermanyUnknown status
Charité Universitätsmedizin Berlin
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BerlinGermanyUnknown status
Vivantes Klinikum am Urban
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BerlinGermanyUnknown status
LWL-Universitätsklinikum Bochum der Ruhr--Universität Bochum, Klinik für Psychiatrie, Psychotherapie und Präventivmedizin
Coordinator of this site? Confirm its status
BochumGermanyUnknown status
KJPP LVR-Klinik Bonn
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BonnGermanyUnknown status
Universitätsklinikum Bonn Klinik für Psychiatrie und Psychotherapie
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BonnGermanyUnknown status
Uniklinik Köln, Klinik und Poliklin-ik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
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CologneGermanyUnknown status
UKD Dresden, Klinik und Poliklinik für Psychiatrie und Psychotherapie
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DresdenGermanyUnknown status
Klinik und Poliklinik für Psychiatrie und Psychotherapie Heinrich-Heine-Universität Düsseldorf
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DüsseldorfGermanyUnknown status
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf {UKE)
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HamburgGermanyUnknown status
Zentrum für Integrative Psychiatrie Kiel
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KielGermanyUnknown status
ZfP Reichenau - Akademisches Lehrkrankenhaus Universität Konstanz
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KonstanzGermanyUnknown status
Zentrum für Integrative Psychiatrie (ZIP) und Fachklinik für Junges Leben (JuLe) Kinder- und Jugendpsychiatrie
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LübeckGermanyUnknown status
Otto-von-Guericke-Universität Magdeburg
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MagdeburgGermanyUnknown status
Zentralinstitut für seelische Gesundheit
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MannheimGermanyUnknown status
Klinikum der Ludwig-Maximilians-Universität München
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MünchenGermanyUnknown status
Institut für Translationale Psychiatrie
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MünsterGermanyUnknown status
Klinik für Psychiatrie und Psychotherapie Universität Tübingen
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TübingenGermanyUnknown status
Zentrum für psychische Gesundheit, U11iversitätsklinikum Würzburg
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WürzburgGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.