NCT06613334Recruiting
Voice-Based Biomarkers: A Novel Approach to Monitoring and Predicting Schizophrenia Relapses
Automatic Measurement of Antipsychotic Medication Adherence in Schizophrenia Through Speech (OBSERVSPEECH)
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 10 Sept 2024
- Start date
- 4 Oct 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- Centre Hospitalier St Anne
- Diseases
- Schizophrenia
- NCT number
- NCT06613334
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 4 Oct 2024 to the primary completion date, Apr 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with lithium salts
- Participant in another study involving medication
Other illness
- Suffering from a neurological pathology: multiple sclerosis, Parkinson's disease, Huntington's disease or neurodegenerative disease
Other
- Suffering from a pathology that impairs French
- Anti-epileptic treatment
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Groupe Hospitalo-Universitaire Paris Psychiatrie & Neurosciences Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.