Clinical trial NCT05563818: Using Speech to Monitor Symptom Severity in Arabic Speaking Patients With Schizophrenia
Official title: Monitoring Symptoms Severity in Arabic Speaking Schizophrenic Patients Using Mobile Phone Speech Analysis: A Proof-of-Concept Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Schizophrenic Disorders
Mental Disorders
Speech
Voice
Language
Natural Language Processing
Behavioral Symptoms
Lead sponsor: Hikma Pharmaceuticals LLC
Sponsor class: INDUSTRY
Collaborators: name: Winterlight Labs
First posted: 2022-10-03
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from four medical sites in the Middle East North Africa (MENA) region, which are located in Jordan, Saudi Arabia, Egypt, and Algeria.

Brief summary: Brief Summary:

Definition: A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.

Limit: 5000 characters. The purpose of this study is to investigate the relationship between speech features and severity of positive and negative clinical symptoms in Arabic speaking patients with schizophrenia. Individuals will be invited to participate in this study because (1) they have a confirmed clinical diagnosis of schizophrenia; (2) they plan to receive routine clinical care for schizophrenia at one of the four participating sites; (3) they speak Arabic as a first language.

Participants must be between the ages of 18-65 years. Participation will involve seven visits consisting of one baseline visit and six monthly follow-up visits. All participants will continue to receive routine clinical care.

Participation in this research will involve providing speech samples using standardized tasks collected using an electronic device. Additionally, study team members will assess positive and negative symptoms of schizophrenia using validated questionnaires.

Detailed description: Speech disorganization is a key feature of schizophrenia. The development of computerized tools to assess speech disorganization is rapidly growing in schizophrenia research. Several early studies showed that changes in speech distinguish schizophrenia patients from healthy controls and assist in differential diagnostics and relapse prevention (1). The Winterlight app can be used for speech collection and assessment and uses speech-based artificial intelligence to identify vocal biomarkers capable of detecting changes in cognitive/clinical symptoms.

Symptom rating scales remain the primary mode of assessing the nature and severity of schizophrenia and the magnitude of any change over time. The Positive and Negative Symptom Scale (PANSS) is a 30-item rating scale that was developed to measure the symptom severity of patients with schizophrenia and assess their dimensions (2). It has been widely used in clinical trials of schizophrenia and is considered as the "gold standard" for the assessment of antipsychotic treatment efficacy.

The goal of this study is to test the hypothesis that quantitative measures derived from speech samples acquired using the Winterlight application will be associated with positive and negative symptom subscores as assessed by the PANSS.

The investigators will use speech-based artificial intelligence methods to identify aspects of voice and language that are related to schizophrenia symptoms in Arabic-speaking patients.

Data collected may be used to evaluate:

1. The relationship between speech measures and PANSS subscores at baseline.
2. The relationship between changes in speech measures and changes in positive symptoms over time.
3. The relationship between changes in speech measures and changes in negative symptoms over time.
4. The ability for speech measures to be used to predict psychotic relapse in individuals with schizophrenia.
5. The feasibility of predicting relapse based on speech and sociodemographic variables.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 - 65 years
2. Confirmed clinical diagnosis of schizophrenia as per the DSM-5 criteria, at any stage of disease.
3. Planned to receive routine clinical care for schizophrenia in the study site for the next 6 months.
4. Arabic is first language

Exclusion Criteria:

1. Illiterate.
2. Catatonic schizophrenia subtype.
3. Neurological disorder or major health problem.
4. Severe substance use disorder using DSM-5 criteria.
5. Risk to self or others.
6. Patient with any speech disorder or treated/planned to be treated with any medication known to impact speech (e.g. first-generation antipsychotics)
7. Patient or family member is unable to provide consent to participate in the study.
8. Participation in another clinical study.

Primary outcomes:
measure: Speech features derived from the Winterlight Assessment (WLA).
timeFrame: up to month 6
measure: Positive and Negative Syndrome Scale (PANSS) including total score, positive subscore, negative subscore and psychopathology subscore.
timeFrame: up to month 6
Secondary outcomes:
measure: Change in speech features derived from the Winterlight Assessment (WLA).
timeFrame: Change from baseline to month 6
measure: Change in Positive and Negative Syndrome Scale (PANSS) including total score, positive subscore, negative subscore and psychopathology subscore. score measured by the PANSS positive sub-score
timeFrame: Change from baseline to month 6
measure: Incidence of psychotic relapse
timeFrame: Change from baseline to month 6
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Mustapha University Hospital
city: Cairo
country: Egypt
facility: Ain Shams Hospital
city: Amman
country: Jordan
facility: Mental Health Hub
city: Jeddah
country: Saudi Arabia
facility: Jeddah Psychiatry Hospital
Study officials:
References:
citation: de Boer JN, Brederoo SG, Voppel AE, Sommer IEC. Anomalies in language as a biomarker for schizophrenia. Curr Opin Psychiatry. 2020 May;33(3):212-218. doi: 10.1097/YCO.0000000000000595.
citation: Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.