SchizophreniaNCT05563818
Using Speech to Monitor Symptom Severity in Arabic Speaking Patients With Schizophrenia
An observational study of Schizophrenia, run by Hikma Pharmaceuticals LLC at 4 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- WinterLight Mobile Phone Speech Analysis
- How many people
- 57 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 9 Nov 2021to 20 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Monitoring Symptoms Severity in Arabic Speaking Schizophrenic Patients Using Mobile Phone Speech Analysis: A Proof-of-Concept Study
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.
Read more
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.
Read the 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:
- The relationship between speech measures and PANSS subscores at baseline.
- The relationship between changes in speech measures and changes in positive symptoms over time.
- The relationship between changes in speech measures and changes in negative symptoms over time.
- The ability for speech measures to be used to predict psychotic relapse in individuals with schizophrenia.
- The feasibility of predicting relapse based on speech and sociodemographic variables.
- Conditions
- Schizophrenia
- Being tested
- WinterLight Mobile Phone Speech Analysis
- Keywords
- Schizophrenia, Schizophrenic Disorders, Mental Disorders, Speech, Voice, Language, Natural Language Processing, Behavioral Symptoms
- Medical subject headings
- Schizophrenia, Mental Disorders, Speech, Language, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WinterLight Mobile Phone Speech AnalysisOther
N/A- observational study
| Study group | Role | What they receive |
|---|---|---|
| Arabic-speaking individuals with schizophrenia | Approximately 56-60 Arabic-speaking individuals with a DSM-5 diagnosis of schizophrenia Receives: Other: WinterLight Mobile Phone Speech Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech features derived from the Winterlight Assessment (WLA).
Acoustic and linguistic measures of speech acquired using the Winterlight Application
Measured: 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.
Measured: up to month 6
Secondary outcomes (3)
Change in speech features derived from the Winterlight Assessment (WLA).
Baseline to endpoint (6 month) change on acoustic and linguistic measures of speech computed based on the WLA.
Measured: 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
Baseline to endpoint (6 month) change on 30-item clinical scale to assess positive and negative symptoms severity in people with schizophrenia
Measured: Change from baseline to month 6
Incidence of psychotic relapse
Psychotic relapse is defined as: hospitalization, suicidal/homicidal ideation, violent behavior, a 25% increase in the PANSS total score, or a significant increase in at least one of several pre-specified PANSS items.
Measured: Change from baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start9 Nov 2021
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hikma Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Winterlight Labs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563818
- Sponsor's protocol ID
- HIK-WL-SCZ-2021-01
- Status last verified
- Feb 2023
- First submitted
- 8 Mar 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32049766Kay 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.
PubMed 3616518
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Symptoms Severity in Arabic Speaking Schizophrenic Patients Using Mobile Phone Speech Analysis: A Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT05563818
- Acronym / sponsor ID
- HIK-WL-SCZ-2021-01
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Schizophrenic Disorders, Mental Disorders, Speech, Voice, Language, Natural Language Processing, Behavioral Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Hikma Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Collaborators
- Winterlight Labs
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The relationship between speech measures and PANSS subscores at baseline.
- The relationship between changes in speech measures and changes in positive symptoms over time.
- The relationship between changes in speech measures and changes in negative symptoms over time.
- The ability for speech measures to be used to predict psychotic relapse in individuals with schizophrenia.
- The feasibility of predicting relapse based on speech and sociodemographic variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arabic-speaking individuals with schizophrenia | – | Other: WinterLight Mobile Phone Speech AnalysisApproximately 56-60 Arabic-speaking individuals with a DSM-5 diagnosis of schizophrenia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Illiterate.
- Catatonic schizophrenia subtype.
- Neurological disorder or major health problem.
- Severe substance use disorder using DSM-5 criteria.
- Risk to self or others.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WinterLight Mobile Phone Speech AnalysisN/A- observational study | Other | Arabic-speaking individuals with schizophrenia |
Primary outcome
Speech features derived from the Winterlight Assessment (WLA).
Time frame: up to month 6
Acoustic and linguistic measures of speech acquired using the Winterlight Application
Positive and Negative Syndrome Scale (PANSS) including total score, positive subscore, negative subscore and psychopathology subscore.
Time frame: up to month 6
30-item clinical scale to assess positive and negative symptoms severity in people with schizophrenia.
3 secondary outcomes
Change in speech features derived from the Winterlight Assessment (WLA).
Time frame: 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
Time frame: Change from baseline to month 6
Incidence of psychotic relapse
Time frame: Change from baseline to month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Background: PubMed 32049766de 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.
- Background: PubMed 3616518Kay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Hikma Pharmaceuticals LLC at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Algeria, Egypt, Jordan, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech features derived from the Winterlight Assessment (WLA). (time frame: up to month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563818, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.