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

NCT06613334 | Recruiting

• 1 other identifier: D23-P038
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Voice interviews recorded on Callyope application

  The analysis of the interviews (acoustic and linguistic features) will be implemented in a voice model predicting a score.

  Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

• Plasma concentration of antipsychotics

  Plasma concentration of antipsychotics measured in ng/mL from Month 0 to Month 6.

  Month 0, Month 2, Month 4, Month 6

Secondary Outcomes (14)

• Age

  Month 0

• Weight

  Month 0

• Sex

  Month 0

• Change from Baseline in the schizophrenia severity

  Month 0, Month 2, Month 4, Month 6

• Change from Baseline in the schizophrenia severity

  Month 0, Month 2, Month 4, Month 6

Study Arms (1)

Schizophrenic patients treated with a primary treatment

EXPERIMENTAL

Study's interventions: * 4 blood tests (inclusion visit, at follow-up visits at 2 and 4 months after inclusion, at the end-of-study visit at 6 months after inclusion) to measure the blood concentration of antipsychotic treatment (risperidone or paliperidone) * completion of self-questionnaires and voice interviews of the application developed by CALLYOPE

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

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.

Schizophrenic patients treated with a primary treatment

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).

Schizophrenic patients treated with a primary treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (2)

Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris

Paris, Paris, 75014, France

RECRUITING

Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences

Paris, 75014, France

NOT YET RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Pierre De Maricourt, Dr

  GHU Paris Psychiatry & Neurosciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre De Maricourt, Dr

CONTACT

(0)1 45 65 86 91; P.DEMARICOURT@ghu-paris.fr

Philippe Domenech, Pr

CONTACT

(0)1 49 81 22 01; philippe.domenech@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with schizophrenia are assigned prospectively to the following experimental interventions: blood tests to measure antipsychotics concentration and the administration of questionnaires/voice tests on the CALLYOPE application.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 25, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): October 4, 2026
• Study Completion (Estimated): October 4, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)