NCT07397975Recruiting
Speech-based Assessment of Relapse Risk in People With Psychosis
A Prospective Multicenter Study for Relapse Risk Assessment Through Language Analysis in Individuals With Psychosis
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
This observational, multinational study assesses the feasibility of speech and self-report data collection across six languages for Artificial Intelligence (AI)-driven relapse risk estimation in psychosis. Over 12 months, patients at risk of relapse and healthy controls will provide weekly speech recordings and self-report data for automated analysis. Risk scores will be stored but not shared with treating clinicians. Independent clinical evaluations ensure data quality and validation. The study lays the foundation for future Clinical Decision Support System (CDSS) research and explores novel speech markers for relapse prediction while minimizing participant burden.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 360 (estimated)
- First submitted
- 22 Jan 2026
- Start date
- 29 Jan 2026
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Philipp Homan
- Diseases
- Schizophrenia
- NCT number
- NCT07397975
What you commit to
- Study type: Observational
- Planned participants: 360
- From 29 Jan 2026 to the primary completion date, 31 Jan 2029
- 7 sites in 6 countries
- 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.
Criteria the registry did not label
- Healthy participants Inclusion Criteria:
- Between 18 and 65 years old.
- Subjects must be able to provide informed consent (IC).
- Participants must have provided signed informed consent prior to enrollment.
- Participants should not take prescription drugs regularly.
- Native or equivalent fluency in speaking and understanding one of the following languages: English, German, Dutch, French, Czech or Turkish.
- Ability to have access to a smartphone and be capable of using a mobile app for speech-based data collection.
- Must be able to comply with the study schedule and procedures.
- Healthy participants Exclusion Criteria:
- Any history of major diseases (e.g., cardiovascular, neurological, metabolic, renal, hepatic, respiratory or speech disorders).
- Recreational drug use or psychiatric disorders due to use of alcohol.
- Depression, anxiety, or other psychiatric disorders.
- Family history of depression, anxiety, or other psychiatric disorders.
- Individuals who are not able or willing to understand the purpose and details of the study.
- Individuals with psychosis Inclusion Criteria:
- Between 18 and 65 years old.
- Diagnoses include psychotic disorders (schizophrenia, schizoaffective disorder, schizophreniform disorder, acute psychosis, bipolar disorder with psychotic symptoms, psychosis not otherwise specified).
- First visit must be during remission phase (baseline measurement).
- Current positive symptoms rated 3 (mild) or lower on all of these Brief Psychiatric Symptom Scale (BPRS) items: hallucinatory behavior, unusual thought content, conceptual disorganization.
- Must be able to comply with the study schedule and procedures.
- Subjects must be able to provide IC.
- Participants must have provided signed informed consent prior to enrollment.
- Native or equivalent fluency in speaking and understanding one of the following languages: English, German, Dutch, French, Czech or Turkish.
- Ability to have access to a smartphone and be capable of using a mobile app for speech-based data collection.
- Individuals with psychosis Exclusion Criteria:
- Severe comorbid speech disorders (aphasia or severe stuttering) that prevent adequate speech recording.
- Individuals who are not able or willing to understand the purpose and details of the investigation.
- Citizens with psychiatric or somatic comorbidity, drug- or alcohol abuse will be allowed to participate, so that the sample will reflect the general population of citizens with psychosis and the study's endpoints will be generalizable.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Geneva and University of Geneva Coordinator of this site? Confirm its status | Geneva | Switzerland | Not yet recruiting |
| Psychiatric University Hospital Zurich and University of Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| National Institute of Mental Health Coordinator of this site? Confirm its status | Klecany | Czechia | Not yet recruiting |
| Newcastle Hospital and RCSI University of Medicine and Health Sciences Coordinator of this site? Confirm its status | Greystones | Ireland | Not yet recruiting |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Not yet recruiting |
| The Arctic University of Norway Coordinator of this site? Confirm its status | Tromsø | Norway | Active, not recruiting |
| Dokuz Eylul University Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Not yet recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.