Adverse Events and Genomics in Schizophrenia

NCT ID: NCT01966588

Last Updated: 2016-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-03-31

Brief Summary

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The purpose of this study is to find genes that predict whether or not a person will develop side effects to antipsychotic medications, such as weight gain, blood sugar dysregulation, or immune cell abnormalities. We will be collecting blood samples from participants who are taking second-generation antipsychotic medications. These blood samples will be stored over the long-term in a biobank, and will be used for later genetic testing and other cell-based studies.

Detailed Description

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All data (including blood samples and medical information gathered from participants) will be labelled with each participant's unique coded identifier. Participants' identities will be matched with their coded identifier in a single, hard-copy of a Master Coding List. The maintenance and security of this list is the responsibility of the Principal Investigator.

All processing steps of the blood samples, including details of the blood draw, nucleic acid extraction, sequence library preparation, and sequence analysis will be documented in a Microsoft Excel worksheet. This worksheet will be encrypted for privacy.

Anonymized aliquots of blood samples (as well as any derived cell cultures) will be barcoded before long-term storage in a surveillance-monitored, secured freezer at -80 degrees Celsius. Samples within the freezer will be maintained via a positional numbered grid within the Laboratory Information Management System. This grid will also allow the study team to link each barcoded sample to a participant's coded identifier.

Mapped genomic sequences and other data collected from participants will be saved in password-protected folders on the UBC server. The coded sequence data will be transferred to the Department of Genetics and Genomic Sciences at Mount Sinai School of Medicine (MSSM) for further analyses. Data transfer will occur by Two Factor Identification. The MSSM secure network is Clinical Laboratory Improvement Amendments (CLIA) certified for secure handling of patient sequence data. The transfer of sequence data between UBC and MSSM will be performed under a material transfer agreement which requires that 1) all data and analysis be confined within the secure, password-protected database defined by UBC, 2) not distributed to any third party, and 3) both raw and analyzed data be destroyed from the MSSM monthly. This study is not required to comply with any U.S. federal regulations, as the group in MSSM will not have access to any identifying information about our participants.

Conditions

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Adverse Effect of Other Antipsychotics and Neuroleptics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metabolic Arm

Blood samples for whole genomic/transcriptomic sequencing; administration of the UKU Side Effect Rating Scale.

Blood samples for whole genomic/transcriptomic sequencing

Intervention Type OTHER

Participants in the Metabolic Arm will receive one blood draw, while participants in the Neutropenia Arm will receive a total of three blood draws: one at baseline, another 3 months later, and one 1 year later, with the possibility of further follow-up.

UKU Side Effect Rating Scale

Intervention Type OTHER

Clinician-rated scale of psychic, neurological, autonomic, and other side effects related to psychotropic drugs; ratings are based on a 10-30 minute interview with each participant.

Neutropenia/Immune System Arm

Blood samples for whole genomic/transcriptomic sequencing

Blood samples for whole genomic/transcriptomic sequencing

Intervention Type OTHER

Participants in the Metabolic Arm will receive one blood draw, while participants in the Neutropenia Arm will receive a total of three blood draws: one at baseline, another 3 months later, and one 1 year later, with the possibility of further follow-up.

Interventions

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Blood samples for whole genomic/transcriptomic sequencing

Participants in the Metabolic Arm will receive one blood draw, while participants in the Neutropenia Arm will receive a total of three blood draws: one at baseline, another 3 months later, and one 1 year later, with the possibility of further follow-up.

Intervention Type OTHER

UKU Side Effect Rating Scale

Clinician-rated scale of psychic, neurological, autonomic, and other side effects related to psychotropic drugs; ratings are based on a 10-30 minute interview with each participant.

Intervention Type OTHER

Other Intervention Names

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UKU Udvalg for Kliniske Undersøgelser

Eligibility Criteria

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Inclusion Criteria

* Must be taking an antipsychotic medication (no limit on treatment duration)

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vancouver Coastal Health

OTHER_GOV

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alasdair M Barr, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

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BC Mental Health and Addictions Research Institute

Vancouver, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Delrae Fawcett, M.Sc.

Role: CONTACT

604-875-2000 ext. 6115

Heidi N Boyda, Ph.D.

Role: CONTACT

604-612-5025

Facility Contacts

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Delrae Fawcett, M.Sc.

Role: primary

604-875-2000 ext. 6115

Heidi N Boyda, Ph.D. (cand)

Role: backup

604-612-5025

Other Identifiers

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H13-00513

Identifier Type: -

Identifier Source: org_study_id

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