Medical-AI trial: using AI to gauge psychosis risk early and act ahead — staged diagnosis and risk-adapted treatment (pronia.ai) (NCT05813080)

1The prodromal window before psychosis

Psychosis, as in schizophrenia, can be preceded before clear onset by warning signs (a prodromal phase) such as anxiety and subtle cognitive or perceptual changes. If people at high risk can be identified at this stage and acted on early, onset might be prevented or softened. But telling who is truly high-risk is hard, which has raised the question of whether AI can help.

2Testing early detection and preemptive treatment

This study tests that early identification and pre-emptive treatment, as a multicenter randomized controlled trial (RCT). Per the registry summary, in patients at increased clinical risk for psychosis, it compares an interventional arm of AI-staged early diagnostics and risk-adapted treatment (RAB) against a control arm of treatment-as-usual (TAU).

The primary outcome uses the Structured Interview for Psychosis-Risk Syndromes (SIPS). The size is 260, at the completed stage.

3Acting after onset, or before it

Psychiatry has grown interested in early intervention — identifying risk in the prodromal phase and acting first rather than responding after onset. Acting early carries its own difficulty.

The study compares an intervention arm receiving AI-based staged early diagnosis and risk-adapted treatment against usual care, in a multicentre randomised controlled trial. The primary endpoint is a structured interview assessing psychosis risk syndromes, across 260 cases, and the study is complete. Prediction of psychosis risk carries large uncertainty, and this study does not establish efficacy.