NCT02431949

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 25, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

April 28, 2015

Last Update Submit

May 24, 2016

Conditions

Keywords

MusicAmusia

Outcome Measures

Primary Outcomes (1)

  • Musical Ability (The Montreal Battery of Evaluation of Amusia)

    Assessment of musical ability based on scores from The Montreal Battery of Evaluation of Amusia

    2 hours

Secondary Outcomes (2)

  • Cognitive Ability (NIH toolbox-cognitive battery scores)

    1 hour

  • Mental Health Symptom Severity (Rating scales from Sci-PANSS and MINI Neuropsychiatric Interview)

    2 hours

Study Arms (2)

Controls

Participants without a psychosis disorder diagnosis.

Patients

Participants with a psychosis disorder diagnosis- recruited from the BC Psychosis Program.

Other: Admission to BCPP

Interventions

There is no intervention associated with this study.

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • For controls and patients:
  • Presence of hearing deficits
  • For controls only, history of:
  • Diagnosis of psychosis disorder
  • Antipsychotic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC psychosis ward at UBC Hospital

Vancouver, British Columbia, Canada

RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Alasdair Barr, PhD

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Delrae Fawcett, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 1, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 25, 2016

Record last verified: 2016-05

Locations