PsychosisBCPP BIODANCT02322918
The BC Psychosis Program Biobank and Database for Genetic Polymorphisms and Their Associations With Psychosis Disorder
An observational study of Psychosis and Schizophrenia, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis, Schizophrenia
- What is being tested?
- Blood samples for whole genomic/transcriptomic sequencing
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Jul 2018
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Admission to BCPP.
- Has provided written informed consent.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia Hospital - BC Psychosis Program
Vancouver, British Columbia, V6T 2A1
Delrae Fawcett, M.Sc., 604-875-2000 ext. 6115, delrae.fawcett@ubc.ca
Heidi N Boyda, Ph.D., 604-875-2000 ext. 6484, heidi.boyda@ubc.ca
About this study
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
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.
Read the 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.
- Conditions
- Psychosis, Schizophrenia
- Being tested
- Blood samples for whole genomic/transcriptomic sequencing
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for whole genomic/transcriptomic sequencingGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants admitted to BCPP | Blood or saliva samples will be collected from participants for whole genomic/transcriptomic sequencing Receives: Genetic: Blood samples for whole genomic/transcriptomic sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
We will determine if specific genetic variants in BDNF and COMT genes are associated with psychosis disorder severity, symptomology and resolution.
Measured: 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.
Measured: One visit during participant's stay at BCPP, an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health
- Responsible party
- Sponsor
- Investigators
- Alasdair M Barr, Ph.D., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322918
- Sponsor's protocol ID
- H14-01136
- Acronym
- BCPP BIODA
- Status last verified
- May 2016
- First submitted
- 12 Dec 2014
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02322918
- Acronym / sponsor ID
- BCPP BIODA / H14-01136
- Conditions
- Psychosis, Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health
- Study start
- Jul 2014
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants admitted to BCPP | – | Genetic: Blood samples for whole genomic/transcriptomic sequencingBlood or saliva samples will be collected from participants for whole genomic/transcriptomic sequencing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Admission to BCPP.
- Has provided written informed consent.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for whole genomic/transcriptomic sequencingParticipant 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. | Genetic | Participants admitted to BCPP |
Primary outcome
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.
2 secondary outcomes
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
Medical Chart Review
Time frame: One visit during participant's stay at BCPP, an expected average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alasdair M Barr, Ph.D. principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis and Schizophrenia, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delrae Fawcett, M.Sc. (604-875-2000 ext. 6115, delrae.fawcett@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.