AI listens for warning signs of psychosis relapse
NCT ID NCT07397975
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether analyzing speech recordings with artificial intelligence can help predict when someone with psychosis might relapse. About 360 participants, including people with psychosis and healthy volunteers, will provide weekly voice samples and answer questions via a smartphone app over 12 months. The goal is to see if this approach is practical and accurate, laying groundwork for future tools that could alert doctors early.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 360 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants at risk of relapse will be recruited from clinical settings while in a stable phase of partial or full remission. Depending on the site, eligible individuals may be either inpatients nearing discharge or outpatients under ongoing care. If the treating clinician considers the patient's mental state sufficiently stable, the study information and consent process may be initiated during inpatient care, prior to discharge. For outpatients, participants may be contacted by phone, or the study can be presented during routine outpatient or day clinic visits. Healthy participants will be recruited through community outreach, advertisements, and volunteer registries from universities and hospitals. healthy participants will be selected to match individuals with psychosis based on key characteristics such as age and sex in each site.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dokuz Eylul University
NOT_YET_RECRUITINGIzmir, Turkey (Türkiye)
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National Institute of Mental Health
NOT_YET_RECRUITINGKlecany, 250 67, Czechia
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Newcastle Hospital and RCSI University of Medicine and Health Sciences
NOT_YET_RECRUITINGGreystones, Wicklow, A63 CD30, Ireland
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Psychiatric University Hospital Zurich and University of Zurich
RECRUITINGZurich, 8032, Switzerland
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The Arctic University of Norway
ACTIVE_NOT_RECRUITINGTromsø, 9037, Norway
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University Hospital Geneva and University of Geneva
NOT_YET_RECRUITINGGeneva, Chêne-Bourg, 1225, Switzerland
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University Medical Center Groningen
NOT_YET_RECRUITINGGroningen, 9713, Netherlands
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