An observational study in Schizophrenia, sponsored by Hikma Pharmaceuticals LLC. Completed at 4 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Hikma Pharmaceuticals LLC · Observational
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.
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:
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 57 is below the median of 178 across 506 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →Hikma Pharmaceuticals LLC is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 56-60 Arabic-speaking individuals with a DSM-5 diagnosis of schizophrenia
Other: WinterLight Mobile Phone Speech Analysis
N/A- observational study
Speech features derived from the Winterlight Assessment (WLA).
Acoustic and linguistic measures of speech acquired using the Winterlight Application
Time frame: 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.
Time frame: up to month 6
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.
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
Baseline to endpoint (6 month) change on 30-item clinical scale to assess positive and negative symptoms severity in people with schizophrenia
Time frame: 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.
Time frame: Change from baseline to month 6
Plan to share: No
Ran from Nov 2021 to primary completion in Dec 2022, 13 months.
Of 136 observational studies under Schizophrenia, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 102. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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