Adverse Events and Genomics in Schizophrenia (AEGIS)

May 30, 2016 updated by: University of British Columbia

Genomic Biomarkers of Adverse Events Arising From Antipsychotic Drug Therapy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4H4
        • Recruiting
        • BC Mental Health and Addictions Research Institute
        • Contact:
        • Principal Investigator:
          • Alasdair M Barr, Ph.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals taking antipsychotic medications (in- or outpatients)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metabolic Arm
Blood samples for whole genomic/transcriptomic sequencing; administration of the UKU Side Effect Rating Scale.
Other: 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.
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.
Other Names:
  • UKU
  • Udvalg for Kliniske Undersøgelser
Neutropenia/Immune System Arm
Blood samples for whole genomic/transcriptomic sequencing
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Concentration of whole-genome and/or transcriptome variants predicting immune effects of clozapine monotherapy in whole blood (ng/uL).
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse effects, as rated by the UKU Side Effect Rating Scale.
Time Frame: 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)
Adverse effects captured by the UKU include psychic/neurological/autonomic/and other side effects.
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)
Frequency of side effects over the last 3 days, as measured by the UKU Side Effects Rating Scale
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Icahn School of Medicine at Mount Sinai
Vancouver Coastal Health

Investigators

  • Principal Investigator: Alasdair M Barr, Ph.D., The University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 21, 2013

Study Record Updates

Last Update Posted (Estimate)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 30, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H13-00513

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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