Clinical trial NCT02322918: The BC Psychosis Program Biobank and Database for Genetic Polymorphisms and Their Associations With Psychosis Disorder
Official title: BC Psychosis Program Biobank and Database for Investigating Genetic Polymorphisms of Brain-derived Neurotrophic Factor and Catechol-o-methyl Transferase and Their Associations With Psychosis Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychosis
Schizophrenia
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health
First posted: 2014-12-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will include all patients who have been admitted to the British Columbia Psychosis Program (BCPP). BCPP provides intensive inpatient care for individuals who have psychosis-related treatment challenges, including pharmacologic, biophysical, and psychosocial services. Admission criteria to BCPP include the following: 1) Must be 18 years or older; 2) Diagnosis of schizophrenia, schizoaffective disorder, mood disorder with psychosis; 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 and 5) If present, substance use disorder, pervasive developmental disorder, developmental disability, personality disorder, aggression, or head injury are not the primary focuses of treatment.

Brief summary: The purpose of this study is to determine if candidate polymorphisms in brain-derived neurotrophic factor (BDNF) and catechol-o-methyl transferase (COMT) are predictive of psychosis disorder severity, symptomology, and resolution in patients at BCPP. A secondary objective will be to form a biorepository of blood and saliva samples from patients at BCPP so that further genetic, proteonomic and pharmacogenomic studies may be done to gain insight into the genetic basis of differences in psychosis disorder presentation and manifestation, and differences in response to antipsychotic drug treatment.

Detailed description: This is a population-based, genetic-association, candidate polymorphism study. It will involve a prospective and a retrospective component. A blood draw or saliva sample will be performed during the participant's admission to BCPP, which may occur at any point during the participant's length of stay. When a participant has been deemed 'Ready for Discharge' by his/her attending psychiatrist at BCPP, a full phenotype will be obtained via retrospective chart review. Genetic analyses and determination of protein levels will be performed after chart review. Following fulfillment of the primary study objective, the remaining blood and saliva samples will be stored in the biobank over the long-term.

Eligibility criteria: Inclusion Criteria:

* Admission to BCPP.
* Has provided written informed consent.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Creation of biorepository of blood samples for future genetic, proteonomic and pharmacogenomic studies.
timeFrame: One visit during participant's stay at BCPP, an expected average of 6 months
Secondary outcomes:
measure: Identification of single-nucleotide polymorphisms (SNPs) in the BDNF and COMT genes
timeFrame: One visit during participant's stay at BCPP, an expected average of 6 months
measure: Medical Chart Review
timeFrame: One visit during participant's stay at BCPP, an expected average of 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia Hospital - BC Psychosis Program
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Alasdair M Barr, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: