Schizophrenia and Related DisordersLPOPNCT05601050
Linguistic Predictors of Outcomes in Psychosis
An observational study of Schizophrenia and Related Disorders, run by Northwell Health at 1 site in United States.
Trial summary
Longitudinal observational study of the relationship between speech patterns and clinical symptoms in schizophrenia spectrum disorders. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Schizophrenia and Related Disorders
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2021to 1 Mar 2023
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Inpatients will be recruited from Northwell Health. Patients whose treatment team believes they would be appropriate for a research study will be approached by research staff and the research project will be explained to them in detail. Potential participants will also be screened for by reviewing newly admitted patients to the inpatient units. Educational seminars regarding this study may be held to inform clinicians and staff of our goals and protocol. Potential participants will be made aware that declining participation will not affect their care.
Who may be able to join
- Speaks English with conversational proficiency
- Current DSM-V-defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, unspecified psychotic disorder, or brief psychotic disorder or bipolar 1 disorder with psychotic features or major depressive disorder with psychotic features using the Structured Clinical Interview for Axis I DSM-V Disorders (SCID-I/P).
- Current significant positive or disorganized symptoms of psychosis (DSM 5 Criterion A) including rating at or above any of the following on the BPRS:
- Grandiosity (Severe - 6)
- Suspiciousness (Moderately Severe - 5)
- Hallucinations (Moderately Severe - 5)
Show all 15Show fewer
- Unusual thought content (Moderate - 4)
- Bizarre Behavior (Moderate - 4)
- Disorientation (Moderate - 4)
- Conceptual Disorganization (Moderate - 4)
- Early phase of psychotic illness as defined by less than 2 years elapsed since reaching threshold for psychotic disorder
- Age 15 to 40 years
- Has capacity and willing to sign informed consent; if minor, parent is willing to give consent and child is willing to give assent.
- Screening will not include a pregnancy test. Pregnant women will not be screened out of the study because the study procedures are of very low risk overall, and pregnancy does not place the participant or the fetus at any significant risk.
- Minors will be included in the study because psychosis symptoms frequently onset before the age of 18 and this patient group is particularly in need of accurate prognosis and treatment. Therefore, it is of vital importance that the conclusions of the study be applicable to minors and that they be included among the participants.
Who cannot join
- Participants with substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, or shared psychotic disorder will not be included.
- Patient currently under the influence of alcohol or drugs.
- Disorders affecting speech or language, such as aphasia, intellectual disability (IQ<70), or language disorder, or movement disorders affecting speech like tardive dyskinesia, or physical impairments causing significant distortions to speech
- Serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain and/or language, including but not limited to: neurodegenerative disorders, traumatic brain injury with active symptoms, autism spectrum disorder, encephalitis, epilepsy
- Significant risk of suicidal or homicidal behavior;
- Cognitive or language limitations, or any other factor that would preclude subjects providing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Longitudinal observational study of the relationship between speech patterns and clinical symptoms in schizophrenia spectrum disorders.
Read the detailed description
The accurate prediction and tracking of clinical and functional outcomes in young people with schizophrenia-spectrum disorders is critical for delivering appropriate interventions and for understanding the brain mechanisms behind psychosis. Language is an optimal avenue for tracking psychosis processes because language is readily produced and captured, has well-established disruptions in psychosis, and known relationship to brain circuits. Using computers to automate detection of language features has the further advantage of being objective, quantitative, and adaptable into an efficient and cost-effective tool. The investigators propose to use automated linguistic analyses in young people early in the course of schizophrenia spectrum disorders to measure language features including fluency (speech rate), complexity (proportion of unique words), prosody (changes in tone during speech), and semantic coherence (how sequencing of words conform to expected patterns).
The investigators will test whether these features meaningfully reflect clinical symptoms, cognition, and functioning, and whether they help predict how psychosis symptoms change over time.
- Conditions
- Schizophrenia and Related Disorders
- Being tested
- There is no intervention
- Keywords
- Schizophrenia, speech, language, language processing, digital health
- Medical subject headings
- Schizophrenia, Speech, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| PSD (Psychosis spectrum disorder) group | Current DSM-V-defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, unspecified psychotic disorder, or brief psychotic disorder, or bipolar 1 disorder with psychotic features or major depressive disorder with psychotic features using the Structured Clinical Interview for Axis I DSM-V Disorders (SCID-I/P). Receives: Other: There is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech features from the Winterlight Speech Assessment
Acoustic and linguistic measures of speech computed based on performance on the Winterlight Speech Assessment.
Measured: 6 months
Secondary outcomes (5)
Brief Psychiatric Rating Scale (BPRS)
18 item, range = 1, not observed - 7, very severe; higher scores resulting in worse outcome.
Measured: 6 months
Hamilton Rating Scale for Depression
24 item, range = 0, absent - 4, severe; higher scores resulting in worse outcome.
Measured: 6 months
Young Mania Rating Scale
11 item, range = 0, absent - 8, severe; higher scores resulting in worse outcome.
Measured: 6 months
Scale for the Assessment of Negative Symptoms
22 item, range= 0, absent - 5, severe; higher scores resulting in worse outcome.
Measured: 6 months
Scale for the Assessment of Thought Language and Communication
20 item, range= 0, absent - 3, severe; higher scores resulting in worse outcome.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start4 Mar 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Winterlight Labs
- Responsible party
- Principal investigator, Sunny Tang, Northwell Health
- Investigators
- Sunny X Tang, MD, Principal investigator, Northwell Health, The Feinstein Institutes of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601050
- Sponsor's protocol ID
- 20-0460
- Acronym
- LPOP
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linguistic Predictors of Outcomes in Psychosis
- ClinicalTrials.gov ID
- NCT05601050
- Acronym / sponsor ID
- LPOP / 20-0460
- Conditions
- Schizophrenia and Related Disorders
- Keywords
- Schizophrenia, speech, language, language processing, digital health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Winterlight Labs
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 1 Nov 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.
Longitudinal observational study of the relationship between speech patterns and clinical symptoms in schizophrenia spectrum disorders.
Detailed description
The accurate prediction and tracking of clinical and functional outcomes in young people with schizophrenia-spectrum disorders is critical for delivering appropriate interventions and for understanding the brain mechanisms behind psychosis. Language is an optimal avenue for tracking psychosis processes because language is readily produced and captured, has well-established disruptions in psychosis, and known relationship to brain circuits. Using computers to automate detection of language features has the further advantage of being objective, quantitative, and adaptable into an efficient and cost-effective tool. The investigators propose to use automated linguistic analyses in young people early in the course of schizophrenia spectrum disorders to measure language features including fluency (speech rate), complexity (proportion of unique words), prosody (changes in tone during speech), and semantic coherence (how sequencing of words conform to expected patterns).
The investigators will test whether these features meaningfully reflect clinical symptoms, cognition, and functioning, and whether they help predict how psychosis symptoms change over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSD (Psychosis spectrum disorder) group | – | Other: There is no interventionCurrent DSM-V-defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, unspecified psychotic disorder, or brief psychotic disorder, or bipolar 1 disorder with psychotic features or major depressive disorder with psychotic features using the Structured Clinical Interview for Axis I DSM-V Disorders (SCID-I/P). |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Inpatients will be recruited from Northwell Health. Patients whose treatment team believes they would be appropriate for a research study will be approached by research staff and the research project will be explained to them in detail. Potential participants will also be screened for by reviewing newly admitted patients to the inpatient units. Educational seminars regarding this study may be held to inform clinicians and staff of our goals and protocol. Potential participants will be made aware that declining participation will not affect their care.
Key inclusion criteria (15 listed)
- Speaks English with conversational proficiency
- Current DSM-V-defined diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, unspecified psychotic disorder, or brief psychotic disorder or bipolar 1 disorder with psychotic features or major depressive disorder with psychotic features using the Structured Clinical Interview for Axis I DSM-V Disorders (SCID-I/P).
- Current significant positive or disorganized symptoms of psychosis (DSM 5 Criterion A) including rating at or above any of the following on the BPRS:
- Grandiosity (Severe - 6)
- Suspiciousness (Moderately Severe - 5)
Key exclusion criteria (6 listed)
- Participants with substance-induced psychotic disorder, a psychotic disorder due to a general medical condition, delusional disorder, or shared psychotic disorder will not be included.
- Patient currently under the influence of alcohol or drugs.
- Disorders affecting speech or language, such as aphasia, intellectual disability (IQ<70), or language disorder, or movement disorders affecting speech like tardive dyskinesia, or physical impairments causing significant distortions to speech
- Serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain and/or language, including but not limited to: neurodegenerative disorders, traumatic brain injury with active symptoms, autism spectrum disorder, encephalitis, epilepsy
- Significant risk of suicidal or homicidal behavior;
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 |
|---|---|---|
| There is no interventionThere is no intervention | Other | PSD (Psychosis spectrum disorder) group |
Primary outcome
Speech features from the Winterlight Speech Assessment
Time frame: 6 months
Acoustic and linguistic measures of speech computed based on performance on the Winterlight Speech Assessment.
5 secondary outcomes
Brief Psychiatric Rating Scale (BPRS)
Time frame: 6 months
Hamilton Rating Scale for Depression
Time frame: 6 months
Young Mania Rating Scale
Time frame: 6 months
Scale for the Assessment of Negative Symptoms
Time frame: 6 months
Scale for the Assessment of Thought Language and Communication
Time frame: 6 month
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 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia and Related Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Schizophrenia, Schizo Affective Disorder
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
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.
Sunny X Tang, MD principal investigator
Northwell Health, The Feinstein Institutes of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Related Disorders, run by Northwell Health at 1 site in United States.
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 15 inclusion and 6 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 from the Winterlight Speech Assessment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2023.