Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders (NCT05813080) | Clinical Trial Compass
CompletedNot Applicable
Computer-assisted Risk Evaluation in the Early Detection of Psychotic Disorders
Germany260 participantsStarted 2023-05-01
Plain-language 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.
Who can participate
Age range
16 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 recruitm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used something called the Structured Interview for Psychosis-Risk Syndromes — can you explain what that assessment involves and whether it's something that might be useful for evaluating my situation?
2Since this trial was focused on early detection and prevention rather than treating an existing psychotic disorder, does my current situation fit the kind of early-risk profile this research was designed to study?
3The trial is now completed — has any data or findings been published yet, and if so, could the computer-assisted risk evaluation approach it tested change how you would assess or monitor me?
4This study was listed as Phase NA, meaning it wasn't testing a drug or device but rather an evaluation tool — does that mean the main value for me is in better diagnosis rather than access to a new treatment?
5Are there any standard clinical pathways for psychosis-risk assessment that you're already using that are similar to what this trial was studying, so I can understand what options are available to me outside of a research setting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Structured Interview for Psychosis-Risk Syndromes (SIPS)