NCT06613334 Voice-Based Biomarkers: a Novel Approach to Monitoring and Predicting Schizophrenia Relapses
| NCT ID | NCT06613334 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier St Anne |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-04 |
| Primary Completion | 2026-10-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-10-04 with a primary completion date of 2026-10-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Pierre De Maricourt, Dr
PRINCIPAL INVESTIGATOR
GHU Paris Psychiatry & Neurosciences
Frequently Asked Questions
Who can join the NCT06613334 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06613334 currently recruiting?
Yes, NCT06613334 is actively recruiting participants. Contact the research team at P.DEMARICOURT@ghu-paris.fr for enrollment information.
Where is the NCT06613334 trial being conducted?
This trial is being conducted at Paris, France, Paris, France.
Who is sponsoring the NCT06613334 clinical trial?
NCT06613334 is sponsored by Centre Hospitalier St Anne. The principal investigator is Pierre De Maricourt, Dr at GHU Paris Psychiatry & Neurosciences. The trial plans to enroll 200 participants.
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