Adverse Events and Genomics in Schizophrenia

• Conditions: Adverse Effect of Other Antipsychotics and Neuroleptics
• Interventions: Other: Blood samples for whole genomic/transcriptomic sequencing; Other: UKU Side Effect Rating Scale

• Registration Number: NCT01966588
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-21
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-30
• Last Update Posted: 2016-06-01
• Primary Completion: 2017-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neutropenia/Immune System Arm	Blood samples for whole genomic/transcriptomic sequencing	Blood samples for whole genomic/transcriptomic sequencing
Metabolic Arm	Blood samples for whole genomic/transcriptomic sequencing	Blood samples for whole genomic/transcriptomic sequencing; administration of the UKU Side Effect Rating Scale.
Metabolic Arm	UKU Side Effect Rating Scale	Blood samples for whole genomic/transcriptomic sequencing; administration of the UKU Side Effect Rating Scale.

Primary Outcome Measures

Name	Time	Method
Concentration of whole-genome and/or transcriptome variants predicting weight gain, or glucose or lipid dysregulations in whole blood (ng/uL).	Anytime during a participant's course of treatment with second-generation antipsychotics (expected average of approximately 1 year after starting treatments)

Secondary Outcome Measures

Name	Time	Method
Concentration of whole-genome and/or transcriptome variants predicting immune effects of clozapine monotherapy in whole blood (ng/uL).	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)

Trial Locations

Locations (1)

BC Mental Health and Addictions Research Institute; 🇨🇦 Vancouver, British Columbia, Canada