RecruitingNot ApplicableNCT06613334

Voice-Based Biomarkers: A Novel Approach to Monitoring and Predicting Schizophrenia Relapses

Automatic Measurement of Antipsychotic Medication Adherence in Schizophrenia Through Speech (OBSERVSPEECH)


Sponsor

Centre Hospitalier St Anne

Enrollment

200 participants

Start Date

Oct 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Schizophrenia is a serious psychiatric illness affecting approximately 25 million people worldwide. Patients with schizophrenia experience hallucinations, auditory illusions, disordered thinking, movement disorders, cognitive impairment and social isolation. Treatments with antipsychotics have proven effective in improving their living conditions, but poor compliance results in relapses and rehospitalizations for the majority of patients, which often results in a worsening of residual symptoms. The prevention of these relapses is a major issue in the care of these patients and frequent monitoring is necessary. The use of a simple, rapid and inexpensive tool to monitor symptoms and treatment effect in schizophrenia could improve the effectiveness of the treatment of these patients and prevent relapses. Speech is a good candidate as a biomarker in the monitoring of patients with schizophrenia. Schizophrenia is accompanied by speech disorders including poor speech, variations in tone or intensity or even difficulties in organizing speech.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study uses voice recordings and AI analysis to detect early warning signs of a schizophrenia relapse. The idea is that changes in how a person speaks — pace, tone, pauses — might signal a worsening episode before it becomes a crisis. Early detection could allow treatment adjustments before hospitalization becomes necessary. **You may be eligible if...** - You have been diagnosed with schizophrenia (DSM-5 criteria) - Your condition is currently stable - You are being treated with one of several specific antipsychotic medications (risperidone, paliperidone, aripiprazole, olanzapine — oral or long-acting injection) - You are covered by a social security or social protection scheme **You may NOT be eligible if...** - You are currently in an acute relapse - You have significant cognitive impairment that prevents completing the study assessments - You are on different antipsychotic medications not covered by the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALBlood test: measurement of plasma antipsychotic concentration

Four blood tests are prospectively realized per patient during the study to measure the plasma concentration of antipsychotics (primary treatment: risperidone/paliperidone, olanzapine or aripiprazole). These blood samples are taken at the inclusion visit, at the follow-up visits 2 and 4 months after the inclusion visit, then at the end-of-study visit 6 months after the inclusion visit.

OTHERVoice interviews and questionnaires carried out via the CALLYOPE application

Voice interviews carried out via the Callyope application: they consist of a series of tests, divided into two parts: Structured tasks (same content for each participant) and Semi-structured tasks (content varies for each participant). The simultaneous analysis of several speech tasks allows us to break down the different stages of speech production and the important factors that influence its achievement. In addition, patients will complete self-questionnaires via the application. Finally, lifestyle habits (sleep duration and number of steps) will be recorded via the application. These different tests will be carried out on the application at the inclusion visit (M0), then every month (M1, M2, M3, M4, M5) until the end of study visit (M6).


Locations(2)

Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris

Paris, Paris, France

Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences

Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06613334


Related Trials