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

NCT05813080 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-03-18

No results posted yet for this 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.

Conditions

  • Psychotic Disorders
  • Prevention

Interventions

DEVICE

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

In addition to the computer-assisted prognosis of risk for reaching a psychosis, all patients assigned to the active treatment arm will receive additional in-depth clinical diagnostics including neuropsychological testing. Adapted psychological treatment will be offered consisting of 16 to 24 sessions over a period of six months.

OTHER

Treatment-as-usual (TAU)

Referral back to the previous care system. Further treatment is left to the referring primary care providers.

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Eva Meisenzahl-Lechner, Prof. · Klinik und Poliklinik für Psychiatrie und Psychotherapie LVR-Klinikum Düsseldorf

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05813080 on ClinicalTrials.gov