The BC Psychosis Program Biobank and Database for Genetic Polymorphisms and Their Associations With Psychosis Disorder (BCPP BIODA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Psychosis
• Intervention / Treatment: Genetic: Blood samples for whole genomic/transcriptomic sequencing

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Delrae Fawcett, M.Sc.; Phone Number: 6115 604-875-2000; Email: delrae.fawcett@ubc.ca
• Study Contact Backup: Name: Heidi Boyda, Ph.D.; Phone Number: 6484 604-875-2000; Email: heidi.boyda@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2A1
      • Recruiting
      • University of British Columbia Hospital - BC Psychosis Program
      • Contact: Delrae Fawcett, M.Sc.; Phone Number: 6115 604-875-2000; Email: delrae.fawcett@ubc.ca
      • Contact: Heidi N Boyda, Ph.D.; Phone Number: 6484 604-875-2000; Email: heidi.boyda@ubc.ca
      • Principal Investigator: Alasdair M Barr, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants admitted to BCPP; Blood or saliva samples will be collected from participants for whole genomic/transcriptomic sequencing

Genetic: Blood samples for whole genomic/transcriptomic sequencing; Participant will receive one blood draw whereby two samples will be extracted. If the participant wishes to participate in the study but is fearful of needles, they may be given the option to provide a saliva sample. A retrospective medical chart review will be performed after participant is discharged from BCPP in order to obtain a full phenotype. Genotyping of BDNF and COMT will be performed. Protein levels of BDNF will be determined. The remaining blood or saliva samples will be stored over the long-term in a biorepository at the BC Mental Health and Addictions Research Institute. A retrospective medical chart review will be completed after the participant is discharged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creation of biorepository of blood samples for future genetic, proteonomic and pharmacogenomic studies.	A biobank of stored samples will be used to determine the genetic variability in psychosis disorder.	One visit during participant's stay at BCPP, an expected average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of single-nucleotide polymorphisms (SNPs) in the BDNF and COMT genes	We will determine if specific genetic variants in BDNF and COMT genes are associated with psychosis disorder severity, symptomology and resolution.	One visit during participant's stay at BCPP, an expected average of 6 months
Medical Chart Review	A medical chart review will be done on hard-copy medical charts at BCPP.	One visit during participant's stay at BCPP, an expected average of 6 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Vancouver Coastal Health
• Investigators: Principal Investigator: Alasdair M Barr, Ph.D., University of British Columbia

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: December 12, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Estimate): June 1, 2016
• Last Update Submitted That Met QC Criteria: May 30, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: H14-01136