The BC Psychosis Program Biobank and Database for Genetic Polymorphisms and Their Associations With Psychosis Disorder

Schizophrenia Clinical Trial

— BCPP BIODA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02322918
• Other study ID #: H14-01136
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2014
• Last updated: May 30, 2016
• Start date: July 2014
• Est. completion date: July 2018

Study information

• Verified date: May 2016
• Source: University of British Columbia
• Contact: Delrae Fawcett, M.Sc.
• Phone: 604-875-2000
• Email: delrae.fawcett[@]ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission to BCPP.

• Has provided written informed consent.

Exclusion Criteria:

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Canada	University of British Columbia Hospital - BC Psychosis Program	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Vancouver Coastal Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No