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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Blood test: measurement of plasma antipsychotic concentration
Biological/VaccineFour 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 interventionVoice 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
Trial outcomes
Primary outcomes
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.
Plasma concentration of antipsychotics
Plasma concentration of antipsychotics measured in ng/mL from Month 0 to Month 6.
Secondary outcomes
Age
Age in years
Weight
Weight in kilograms
Sex
Sex (Male / Female)
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.
Sponsors and contacts
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