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

ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCentre Hospitalier St Anne

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood test: measurement of plasma antipsychotic concentration

    Biological/Vaccine

    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 intervention

    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).

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Schizophrenic patients treated with a primary treatmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

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

Plasma concentration of antipsychotics

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

Time frame
Month 0, Month 2, Month 4, Month 6

Secondary outcomes

1

Age

Age in years

Time frame
Month 0
2

Weight

Weight in kilograms

Time frame
Month 0
3

Sex

Sex (Male / Female)

Time frame
Month 0
4

Change from Baseline in the schizophrenia severity

Schizophrenia severity will be assessed by the investigator with PANSS (Positive and Negative Syndrome Scale) scale. For positive symptoms, score range is 7-49; For negative symptoms, the score range is 16 to 112. Higher score mean a worse outcome.

Time frame
Month 0, Month 2, Month 4, Month 6

Other outcomes

Sponsors and contacts

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