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

NCT02322918 | Unknown

• 1 other identifier: H14-01136
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Identification of single-nucleotide polymorphisms (SNPs) in the BDNF and COMT genes

  One visit during participant's stay at BCPP, an expected average of 6 months

• Medical Chart Review

  One visit during participant's stay at BCPP, an expected average of 6 months

Study Arms (1)

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

Interventions

Blood samples for whole genomic/transcriptomic sequencing GENETIC

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.

Participants admitted to BCPP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Coastal Health: collaborator

Study Sites (1)

University of British Columbia Hospital - BC Psychosis Program

Vancouver, British Columbia, V6T 2A1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will be collecting and retaining whole blood samples and saliva samples for genomic testing.

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alasdair M Barr, Ph.D.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delrae Fawcett, M.Sc.

CONTACT

604-875-2000; delrae.fawcett@ubc.ca

Heidi Boyda, Ph.D.

CONTACT

604-875-2000; heidi.boyda@ubc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 23, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

CA (1)