Using Speech to Monitor Symptom Severity in Arabic Speaking Patients With Schizophrenia

NCT05563818 | Completed

• 1 other identifier: HIK-WL-SCZ-2021-01
• Study Type: observational
• Target: 57
• Locations: 4 countries
• Sites: 4

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Schizophrenic Disorders; Mental Disorders; Speech; Voice; Language; Natural Language Processing; Behavioral Symptoms

Outcome Measures

Primary Outcomes (2)

• Speech features derived from the Winterlight Assessment (WLA).

  Acoustic and linguistic measures of speech acquired using the Winterlight Application

  up to month 6

• Positive and Negative Syndrome Scale (PANSS) including total score, positive subscore, negative subscore and psychopathology subscore.

  30-item clinical scale to assess positive and negative symptoms severity in people with schizophrenia.

  up to month 6

Secondary Outcomes (3)

• Change in speech features derived from the Winterlight Assessment (WLA).

  Change from baseline to month 6

• 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

  Change from baseline to month 6

• Incidence of psychotic relapse

  Change from baseline to month 6

Study Arms (1)

Arabic-speaking individuals with schizophrenia

Approximately 56-60 Arabic-speaking individuals with a DSM-5 diagnosis of schizophrenia

Other: WinterLight Mobile Phone Speech Analysis

Interventions

WinterLight Mobile Phone Speech Analysis OTHER

N/A- observational study

Arabic-speaking individuals with schizophrenia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hikma Pharmaceuticals LLC: lead
• Winterlight Labs: collaborator

Study Sites (4)

Mustapha University Hospital

Algiers, Algeria

Location

Ain Shams Hospital

Cairo, Egypt

Location

Mental Health Hub

Amman, Jordan

Location

Jeddah Psychiatry Hospital

Jeddah, Saudi Arabia

Location

Related Publications (2)

• 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.

  PMID: 32049766 BACKGROUND

• 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.

  PMID: 3616518 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Speech; Language; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Verbal Behavior; Communication; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: October 3, 2022
• Study Start: November 9, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: September 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1); JO (1); EG (1); AL (1)