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Adverse Events and Genomics in Schizophrenia (AEGIS)

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ClinicalTrials.gov Identifier: NCT01966588
Recruitment Status : Unknown
Verified May 2016 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : October 21, 2013
Last Update Posted : June 1, 2016
Sponsor:
Collaborators:
Vancouver Coastal Health
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
University of British Columbia

Tracking Information
First Submitted Date June 28, 2013
First Posted Date October 21, 2013
Last Update Posted Date June 1, 2016
Study Start Date June 2013
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2013)
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) ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01966588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 16, 2013)
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) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 16, 2013)
  • 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.
  • 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) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Adverse Events and Genomics in Schizophrenia
Official Title Genomic Biomarkers of Adverse Events Arising From Antipsychotic Drug Therapy
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Retention:   Samples With DNA
Description:
We will be collecting and retaining whole blood samples for genomic testing.
Sampling Method Non-Probability Sample
Study Population Individuals taking antipsychotic medications (in- or outpatients)
Condition Adverse Effect of Other Antipsychotics and Neuroleptics
Intervention
  • 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
Study Groups/Cohorts
  • Metabolic Arm
    Blood samples for whole genomic/transcriptomic sequencing; administration of the UKU Side Effect Rating Scale.
    Interventions:
    • Other: Blood samples for whole genomic/transcriptomic sequencing
    • Other: UKU Side Effect Rating Scale
  • Neutropenia/Immune System Arm
    Blood samples for whole genomic/transcriptomic sequencing
    Intervention: Other: Blood samples for whole genomic/transcriptomic sequencing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 16, 2013)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01966588
Other Study ID Numbers H13-00513
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of British Columbia
Study Sponsor University of British Columbia
Collaborators
  • Vancouver Coastal Health
  • Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Alasdair M Barr, Ph.D. The University of British Columbia
PRS Account University of British Columbia
Verification Date May 2016