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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

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.

Condition or disease Intervention/treatment
Adverse Effect of Other Antipsychotics and Neuroleptics Other: Blood samples for whole genomic/transcriptomic sequencing Other: UKU Side Effect Rating Scale

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Genomic Biomarkers of Adverse Events Arising From Antipsychotic Drug Therapy
Study Start Date : June 2013
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]

Other Outcome Measures:
  1. 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.

  2. 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) ]

Biospecimen Retention:   Samples With DNA
We will be collecting and retaining whole blood samples for genomic testing.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals taking antipsychotic medications (in- or outpatients)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966588


Contacts
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Contact: Delrae Fawcett, M.Sc. 604-875-2000 ext 6115 delrae.fawcett@ubc.ca
Contact: Heidi N Boyda, Ph.D. 604-612-5025 hnboyda@gmail.com

Locations
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Canada, British Columbia
BC Mental Health and Addictions Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z 4H4
Contact: Delrae Fawcett, M.Sc.    604-875-2000 ext 6115    delrae.fawcett@ubc.ca   
Contact: Heidi N Boyda, Ph.D. (cand)    604-612-5025    hnboyda@gmail.com   
Principal Investigator: Alasdair M Barr, Ph.D.         
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Alasdair M Barr, Ph.D. The University of British Columbia

Additional Information:

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01966588     History of Changes
Other Study ID Numbers: H13-00513
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Keywords provided by University of British Columbia:
Antipsychotic agents
Adverse effects
Genomics
Transcriptome
Additional relevant MeSH terms:
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Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs