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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Centre Hospitalier St Anne • ClinicalTrials.gov ID: NCT06613334

Registry updated: 2026-09-21
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Description

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.

Interventions

  • Blood test: measurement of plasma antipsychotic concentration (Biological)
    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.
  • Voice interviews and questionnaires carried out via the CALLYOPE application (Other)
    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).

Eligibility criteria

Inclusion Criteria: * Affiliated to a social security or other social protection scheme * Diagnosed with schizophrenia according to the DSM-5 (code F20) * Stable state without duration criteria * Main treatment with risperidone or paliperidone, aripiprazole, olanzapine in oral or long-acting injectable form * Complementary treatment with an antipsychotic for anxiolytic or sedative purposes: chlorpromazine, loxapine or cyamemazine * Able to speak and read French * Able to perform speech evaluations * Able to answer questionnaires on smartphone * May be under curatorship or guardianship * Agreeing to participate in the study and with informed consent signed by the subject, as well as by the legal representative in the case of a person under curatorship or guardianship Exclusion Criteria: * Suffering from a pathology that impairs French * Suffering from a neurological pathology: multiple sclerosis, Parkinson's disease, Huntington's disease or neurodegenerative disease * Treatment with lithium salts * Anti-epileptic treatment * Participant in another study involving medication

Conditions

Schizophrenia

Locations

  • Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris — Paris, Paris, France
  • Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences — Paris, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record