Clinical trial NCT01966588: Adverse Events and Genomics in Schizophrenia
Official title: Genomic Biomarkers of Adverse Events Arising From Antipsychotic Drug Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adverse Effect of Other Antipsychotics and Neuroleptics
Keywords: Antipsychotic agents
Adverse effects
Genomics
Transcriptome
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health
name: Icahn School of Medicine at Mount Sinai
First posted: 2013-10-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals taking antipsychotic medications (in- or outpatients)

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Concentration of whole-genome and/or transcriptome variants predicting weight gain, or glucose or lipid dysregulations in whole blood (ng/uL).
timeFrame: Anytime during a participant's course of treatment with second-generation antipsychotics (expected average of approximately 1 year after starting treatments)
Secondary outcomes:
measure: Concentration of whole-genome and/or transcriptome variants predicting immune effects of clozapine monotherapy in whole blood (ng/uL).
timeFrame: Baseline (at time of enrolment; expected average of approximately 1 year after starting treatment), 3 months after baseline, and 1 year after baseline (with possibility of further follow-up)
Other outcomes:
measure: Number of adverse effects, as rated by the UKU Side Effect Rating Scale.
timeFrame: Performed at the baseline blood draw for participants in both arms (at the time of enrolment into study; expected average of approximately 1 year after starting treatments)
measure: Frequency of side effects over the last 3 days, as measured by the UKU Side Effects Rating Scale
timeFrame: Performed at the baseline blood draw for participants in both arms (at the time of enrolment; expected average of approximately 1 year after starting treatments)
Locations:
city: Vancouver
country: Canada
facility: BC Mental Health and Addictions Research Institute
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Alasdair M Barr, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: