SchizophreniaMARSNCT02431949
The Music Study in Refractory Psychosis
An observational study of Schizophrenia and Psychosis, run by University of British Columbia at 1 site in Canada.
Trial summary
The perception of music requires coordinated neural activities in distributed multi-functional centers across both hemispheres. The association between musical abilities and other general cognitive functions have been studied in several populations with inconsistent results. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychosis
- What is being tested?
- Admission to BCPP
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to May 2017
- How long will I take part?
- 2 Weeks
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participant population will include all patients who have been admitted to the British Columbia Psychosis Progarm (BCPP) at the University of British Columbia (UBC) Hospital. Admission criteria to BCPP include the following: 1) Must be 18 years or older who are medically stable; 2) Diagnosis of schizophrenia, schizoaffective disorder, mood disorder with psychosis, or non-substance-related psychosis requiring diagnostic clarification; 3) History of no response or inadequate response of positive symptoms to at least 2 adequate trials of antipsychotics (one of which is a second generation agent) by health authority tertiary clinical teams; 4) Incomplete recovery of social, vocational, and occupational functioning likely to respond to active intervention. Control subjects will be age and gender matched with patient participants.
Who may be able to join
- Admission to BC Psychosis Program at UBC Hospital in Vancouver, B.C. with a diagnosis of a psychosis disorder (patients only)
- Fluency in English (patients and controls)
- Able to give consent
Who cannot join
- For controls and patients:
- Presence of hearing deficits
- For controls only, history of:
- Diagnosis of psychosis disorder
- Antipsychotic medications
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC psychosis ward at UBC Hospital
Vancouver, British Columbia
Delrae Fawcett, 604-875-2000 x6115, delrae.fawcett@ubc.ca
About this study
Official title: A Cross-sectional Analysis of Musical Ability in Patients With Refractory Schizophrenia
The perception of music requires coordinated neural activities in distributed multi-functional centers across both hemispheres. The association between musical abilities and other general cognitive functions have been studied in several populations with inconsistent results.
Schizophrenia is a major mental disorder that is strongly associated with cognitive deficits. These often appear before the onset of psychotic symptoms and persist throughout effective treatment of positive and negative symptoms. Like other disorders of psychosis, schizophrenia features general deficits in auditory memory and sensory processing. Recently, Sawada et al. (2014) and Wen et al. (2014) studied music abilities in Japanese and Chinese schizophrenic populations. They both used a standardized assessment for amusia called Montreal Battery of Evaluation of Amusia (MBEA) and found marked impairments in perception of scale, contour, interval, rhythm, meter and memory. Both studies showed that deficits in music perception were associated with cognitive deficits and negative symptoms. In regards to positive symptoms, Wen et al., but not Sawada et al., found a significant association.
The present clinical study will assess musical abilities using the MBEA in a Canadian population with and without refractory psychosis. It will explore associations between musical deficits, positive and negative psychiatric symptomology and cognition. The patient population will have a diagnosis of schizophrenia, schizoaffective disorder, affective disorder with psychosis or non substance-related psychosis who were referred to the British Columbia Psychosis Program (BCPP) due to inadequate or no response to at least two trials of antipsychotics. A focus on refractory psychosis may provide greater insights because these patients have relatively more pronounced psychiatric symptoms and cognitive deficits. It will also be valuable to administer the MBEA assessment on a Canadian population, because the test was originally intended for Western populations and its musical phrases were designed with Western tonalities.
Read the detailed description
- BACKGROUND, PURPOSE AND JUSTIFICATION The perception of music requires coordinated neural activities in distributed multi-functional centers across both hemispheres. The association between musical abilities and other general cognitive functions have been studied in several populations with inconsistent results. Schizophrenia is a major mental disorder that is strongly associated with cognitive deficits. These often appear before the onset of psychotic symptoms and persist throughout effective treatment of positive and negative symptoms. Like other disorders of psychosis, schizophrenia features general deficits in auditory memory and sensory processing. Recently, Sawada et al. (2014) and Wen et al. (2014) studied music abilities in Japanese and Chinese schizophrenic populations. They both used a standardized assessment for amusia called Montreal Battery of Evaluation of Amusia (MBEA) and found marked impairments in perception of scale, contour, interval, rhythm, meter and memory. Both studies showed that deficits in music perception were associated with cognitive deficits and negative symptoms. In regards to positive symptoms, Wen et al., but not Sawada et al., found a significant association. The present clinical study will assess musical abilities using the MBEA in a Canadian population with and without refractory psychosis. It will explore associations between musical deficits, positive and negative psychiatric symptomology and cognition. The patient population will have a diagnosis of schizophrenia, schizoaffective disorder, affective disorder with psychosis or non substance-related psychosis who were referred to the British Columbia Psychosis Program (BCPP) due to inadequate or no response to at least two trials of antipsychotics. A focus on refractory psychosis may provide greater insights because these patients have relatively more pronounced psychiatric symptoms and cognitive deficits. It will also be valuable to administer the MBEA assessment on a Canadian population, because the test was originally intended for Western populations and its musical phrases were designed with Western tonalities.
- RESEARCH OUTLINE This is a cross-sectional, observational study. Participating patients with refractory psychosis and healthy (age- and gender- matched) controls will undergo the Montreal Battery of Evaluation of Amusia assessment and assessments of cognition and symptoms.
The purpose of the study is to describe music perceptive ability in patients with refractory psychosis using the Montreal Battery of Evaluation of Amusia, a standardized and continuous measure of musical ability. The criterion for amusia is a score of 2 standard deviations below the mean of normal participants.
- OBJECTIVES
Primary:
The primary objective is to compare music perceptive ability in patients with clinically identified refractory psychosis with healthy subjects.
Secondary:
The secondary objectives are to compare the prevalence of amusia in a population of patients with refractory psychosis versus a population of healthy controls, and to compare psychiatric symptoms and cognition in patients with amusia versus patients without amusia. We will also determine if an association exists between music perceptive ability and:
- General and specific aspects of symptom severity, as assessed by standardized symptom rating scales and neurological status examination.
- General and specific aspects of cognition, as assessed by cognitive tests.
- Demographic variables such as sex, age, musical training and education. In addition, we will investigate potential pathways between symptomologies of psychosis, cognitive deficits and musical disability (if found) by using exploratory mediation analysis.
- RESEARCH METHOD We will recruit 100 participants, who will undergo the Montreal Battery of Evaluation of Amusia test and cognitive tests. Of these, 50 will be age- and gender- matched participants not diagnosed with a psychosis disorder who will serve as controls. The remaining 50 participants will be recruited from BCPP at UBC Hospital for in-patients diagnosed with refractory psychosis. For patients, participation will also involve assessments of their mental health (psychiatric symptoms).
- STATISTICAL ANALYSIS Inferential analyses will be used to assess differences in musical ability between patients and controls. It will also be used to evaluate differences in psychiatric symptoms and cognition between patients with amusia and those without amusia. Linear regression analyses will be done to relate psychiatric symptoms and cognition to musical ability. Mediation analyses will be performed to determine a causal model between symptoms, cognition and musical ability.
- Conditions
- Schizophrenia, Psychosis
- Being tested
- Admission to BCPP
- Keywords
- Music, Amusia
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Admission to BCPPOther
There is no intervention associated with this study.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Participants without a psychosis disorder diagnosis. | |
| Patients | Participants with a psychosis disorder diagnosis- recruited from the BC Psychosis Program. Receives: Other: Admission to BCPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musical Ability (The Montreal Battery of Evaluation of Amusia)
Assessment of musical ability based on scores from The Montreal Battery of Evaluation of Amusia
Measured: 2 hours
Secondary outcomes (2)
Cognitive Ability (NIH toolbox-cognitive battery scores)
NIH toolbox-cognitive battery scores.
Measured: 1 hour
Mental Health Symptom Severity (Rating scales from Sci-PANSS and MINI Neuropsychiatric Interview)
Rating scales from Sci-PANSS and MINI Neuropsychiatric Interview.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alasdair Barr, PhD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431949
- Sponsor's protocol ID
- H14-02891
- Acronym
- MARS
- Status last verified
- May 2016
- First submitted
- 28 Apr 2015
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Analysis of Musical Ability in Patients With Refractory Schizophrenia
- ClinicalTrials.gov ID
- NCT02431949
- Acronym / sponsor ID
- MARS / H14-02891
- Conditions
- Schizophrenia, Psychosis
- Keywords
- Music, Amusia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 1 May 2015 (estimated)
- 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.
The perception of music requires coordinated neural activities in distributed multi-functional centers across both hemispheres. The association between musical abilities and other general cognitive functions have been studied in several populations with inconsistent results.
Schizophrenia is a major mental disorder that is strongly associated with cognitive deficits. These often appear before the onset of psychotic symptoms and persist throughout effective treatment of positive and negative symptoms. Like other disorders of psychosis, schizophrenia features general deficits in auditory memory and sensory processing. Recently, Sawada et al. (2014) and Wen et al. (2014) studied music abilities in Japanese and Chinese schizophrenic populations. They both used a standardized assessment for amusia called Montreal Battery of Evaluation of Amusia (MBEA) and found marked impairments in perception of scale, contour, interval, rhythm, meter and memory. Both studies showed that deficits in music perception were associated with cognitive deficits and negative symptoms. In regards to positive symptoms, Wen et al., but not Sawada et al., found a significant association.
The present clinical study will assess musical abilities using the MBEA in a Canadian population with and without refractory psychosis. It will explore associations between musical deficits, positive and negative psychiatric symptomology and cognition. The patient population will have a diagnosis of schizophrenia, schizoaffective disorder, affective disorder with psychosis or non substance-related psychosis who were referred to the British Columbia Psychosis Program (BCPP) due to inadequate or no response to at least two trials of antipsychotics. A focus on refractory psychosis may provide greater insights because these patients have relatively more pronounced psychiatric symptoms and cognitive deficits. It will also be valuable to administer the MBEA assessment on a Canadian population, because the test was originally intended for Western populations and its musical phrases were designed with Western tonalities.
Detailed description
- BACKGROUND, PURPOSE AND JUSTIFICATION The perception of music requires coordinated neural activities in distributed multi-functional centers across both hemispheres. The association between musical abilities and other general cognitive functions have been studied in several populations with inconsistent results. Schizophrenia is a major mental disorder that is strongly associated with cognitive deficits. These often appear before the onset of psychotic symptoms and persist throughout effective treatment of positive and negative symptoms. Like other disorders of psychosis, schizophrenia features general deficits in auditory memory and sensory processing. Recently, Sawada et al. (2014) and Wen et al. (2014) studied music abilities in Japanese and Chinese schizophrenic populations. They both used a standardized assessment for amusia called Montreal Battery of Evaluation of Amusia (MBEA) and found marked impairments in perception of scale, contour, interval, rhythm, meter and memory. Both studies showed that deficits in music perception were associated with cognitive deficits and negative symptoms. In regards to positive symptoms, Wen et al., but not Sawada et al., found a significant association. The present clinical study will assess musical abilities using the MBEA in a Canadian population with and without refractory psychosis. It will explore associations between musical deficits, positive and negative psychiatric symptomology and cognition. The patient population will have a diagnosis of schizophrenia, schizoaffective disorder, affective disorder with psychosis or non substance-related psychosis who were referred to the British Columbia Psychosis Program (BCPP) due to inadequate or no response to at least two trials of antipsychotics. A focus on refractory psychosis may provide greater insights because these patients have relatively more pronounced psychiatric symptoms and cognitive deficits. It will also be valuable to administer the MBEA assessment on a Canadian population, because the test was originally intended for Western populations and its musical phrases were designed with Western tonalities.
- RESEARCH OUTLINE This is a cross-sectional, observational study. Participating patients with refractory psychosis and healthy (age- and gender- matched) controls will undergo the Montreal Battery of Evaluation of Amusia assessment and assessments of cognition and symptoms.
The purpose of the study is to describe music perceptive ability in patients with refractory psychosis using the Montreal Battery of Evaluation of Amusia, a standardized and continuous measure of musical ability. The criterion for amusia is a score of 2 standard deviations below the mean of normal participants.
- OBJECTIVES
Primary:
The primary objective is to compare music perceptive ability in patients with clinically identified refractory psychosis with healthy subjects.
Secondary:
The secondary objectives are to compare the prevalence of amusia in a population of patients with refractory psychosis versus a population of healthy controls, and to compare psychiatric symptoms and cognition in patients with amusia versus patients without amusia. We will also determine if an association exists between music perceptive ability and:
- General and specific aspects of symptom severity, as assessed by standardized symptom rating scales and neurological status examination.
- General and specific aspects of cognition, as assessed by cognitive tests.
- Demographic variables such as sex, age, musical training and education. In addition, we will investigate potential pathways between symptomologies of psychosis, cognitive deficits and musical disability (if found) by using exploratory mediation analysis.
- RESEARCH METHOD We will recruit 100 participants, who will undergo the Montreal Battery of Evaluation of Amusia test and cognitive tests. Of these, 50 will be age- and gender- matched participants not diagnosed with a psychosis disorder who will serve as controls. The remaining 50 participants will be recruited from BCPP at UBC Hospital for in-patients diagnosed with refractory psychosis. For patients, participation will also involve assessments of their mental health (psychiatric symptoms).
- STATISTICAL ANALYSIS Inferential analyses will be used to assess differences in musical ability between patients and controls. It will also be used to evaluate differences in psychiatric symptoms and cognition between patients with amusia and those without amusia. Linear regression analyses will be done to relate psychiatric symptoms and cognition to musical ability. Mediation analyses will be performed to determine a causal model between symptoms, cognition and musical ability.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Participants without a psychosis disorder diagnosis. |
| Patients | – | Other: Admission to BCPPParticipants with a psychosis disorder diagnosis- recruited from the BC Psychosis Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participant population will include all patients who have been admitted to the British Columbia Psychosis Progarm (BCPP) at the University of British Columbia (UBC) Hospital. Admission criteria to BCPP include the following: 1) Must be 18 years or older who are medically stable; 2) Diagnosis of schizophrenia, schizoaffective disorder, mood disorder with psychosis, or non-substance-related psychosis requiring diagnostic clarification; 3) History of no response or inadequate response of positive symptoms to at least 2 adequate trials of antipsychotics (one of which is a second generation agent) by health authority tertiary clinical teams; 4) Incomplete recovery of social, vocational, and occupational functioning likely to respond to active intervention. Control subjects will be age and gender matched with patient participants.
Key inclusion criteria (3 listed)
- Admission to BC Psychosis Program at UBC Hospital in Vancouver, B.C. with a diagnosis of a psychosis disorder (patients only)
- Fluency in English (patients and controls)
- Able to give consent
Key exclusion criteria (5 listed)
- Presence of hearing deficits
- Diagnosis of psychosis disorder
- Antipsychotic medications
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 |
|---|---|---|
| Admission to BCPPThere is no intervention associated with this study. | Other | Patients |
Primary outcome
Musical Ability (The Montreal Battery of Evaluation of Amusia)
Time frame: 2 hours
Assessment of musical ability based on scores from The Montreal Battery of Evaluation of Amusia
2 secondary outcomes
Cognitive Ability (NIH toolbox-cognitive battery scores)
Time frame: 1 hour
Mental Health Symptom Severity (Rating scales from Sci-PANSS and MINI Neuropsychiatric Interview)
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
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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.
Alasdair Barr, PhD principal investigator
The University of British Columbia
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 Psychosis, run by University of British Columbia at 1 site in Canada.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 May 2016. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sujin Im, BSc (778-899-5969, sujinim92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musical Ability (The Montreal Battery of Evaluation of Amusia) (time frame: 2 hours). 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 25 May 2016; AzTrials last refreshed its copy on 1 Nov 2026.