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

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ClinicalTrials.gov Identifier: NCT02322918
Recruitment Status : Recruiting
First Posted : December 23, 2014
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
Vancouver Coastal Health
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment
Psychosis Schizophrenia 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 [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Target Follow-Up Duration: 6 Months
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 Start Date : July 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


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.




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


Secondary Outcome Measures :
  1. Identification of single-nucleotide polymorphisms (SNPs) in the BDNF and COMT genes [ Time Frame: One visit during participant's stay at BCPP, an expected average of 6 months ]
    We will determine if specific genetic variants in BDNF and COMT genes are associated with psychosis disorder severity, symptomology and resolution.

  2. Medical Chart Review [ Time Frame: One visit during participant's stay at BCPP, an expected average of 6 months ]
    A medical chart review will be done on hard-copy medical charts at BCPP.


Biospecimen Retention:   Samples With DNA
We will be collecting and retaining whole blood samples and saliva samples for genomic testing.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322918


Contacts
Contact: Delrae Fawcett, M.Sc. 604-875-2000 ext 6115 delrae.fawcett@ubc.ca
Contact: Heidi Boyda, Ph.D. 604-875-2000 ext 6484 heidi.boyda@ubc.ca

Locations
Canada, British Columbia
University of British Columbia Hospital - BC Psychosis Program Recruiting
Vancouver, British Columbia, Canada, V6T 2A1
Contact: Delrae Fawcett, M.Sc.    604-875-2000 ext 6115    delrae.fawcett@ubc.ca   
Contact: Heidi N Boyda, Ph.D.    604-875-2000 ext 6484    heidi.boyda@ubc.ca   
Principal Investigator: Alasdair M Barr, Ph.D.         
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health
Investigators
Principal Investigator: Alasdair M Barr, Ph.D. University of British Columbia

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02322918     History of Changes
Other Study ID Numbers: H14-01136
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders