Adverse Effect of Other Antipsychotics and NeurolepticsAEGISNCT01966588
Adverse Events and Genomics in Schizophrenia
An observational study of Adverse Effect of Other Antipsychotics and Neuroleptics, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adverse Effect of Other Antipsychotics and Neuroleptics
- What is being tested?
- Blood samples for whole genomic/transcriptomic sequencing and UKU Side Effect Rating Scale
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Mar 2017
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals taking antipsychotic medications (in- or outpatients)
Who may be able to join
- Must be taking an antipsychotic medication (no limit on treatment duration)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
BC Mental Health and Addictions Research Institute
Vancouver, British Columbia, V5Z 4H4
Delrae Fawcett, M.Sc., 604-875-2000 ext. 6115, delrae.fawcett@ubc.ca
Heidi N Boyda, Ph.D. (cand), 604-612-5025, hnboyda@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Blood samples for whole genomic/transcriptomic sequencing, UKU Side Effect Rating Scale
- Keywords
- Antipsychotic agents, Adverse effects, Genomics, Transcriptome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for whole genomic/transcriptomic sequencingOther
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.
UKU Side Effect Rating ScaleOther
Also called UKU, Udvalg for Kliniske Undersøgelser
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.
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Arm | Blood samples for whole genomic/transcriptomic sequencing; administration of the UKU Side Effect Rating Scale. Receives: 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 Receives: Other: Blood samples for whole genomic/transcriptomic sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of whole-genome and/or transcriptome variants predicting weight gain, or glucose or lipid dysregulations in whole blood (ng/uL).
Measured: Anytime during a participant's course of treatment with second-generation antipsychotics (expected average of approximately 1 year after starting treatments)
Secondary outcomes (1)
Concentration of whole-genome and/or transcriptome variants predicting immune effects of clozapine monotherapy in whole blood (ng/uL).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effect of Other Antipsychotics and NeurolepticsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health, Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Alasdair M Barr, Ph.D., Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966588
- Sponsor's protocol ID
- H13-00513
- Acronym
- AEGIS
- Status last verified
- May 2016
- First submitted
- 28 Jun 2013
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Biomarkers of Adverse Events Arising From Antipsychotic Drug Therapy
- ClinicalTrials.gov ID
- NCT01966588
- Acronym / sponsor ID
- AEGIS / H13-00513
- Keywords
- Antipsychotic agents, Adverse effects, Genomics, Transcriptome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health, Icahn School of Medicine at Mount Sinai
- Study start
- Jun 2013
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 21 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metabolic Arm | – | Other: Blood samples for whole genomic/transcriptomic sequencing, Other: UKU Side Effect Rating ScaleBlood samples for whole genomic/transcriptomic sequencing; administration of the UKU Side Effect Rating Scale. |
| Neutropenia/Immune System Arm | – | Other: Blood samples for whole genomic/transcriptomic sequencingBlood samples for whole genomic/transcriptomic sequencing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals taking antipsychotic medications (in- or outpatients)
Key inclusion criteria (1 listed)
- Must be taking an antipsychotic medication (no limit on treatment duration)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for whole genomic/transcriptomic sequencingParticipants 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 | Metabolic Arm, Neutropenia/Immune System Arm |
| UKU Side Effect Rating ScaleAlso: UKU, Udvalg for Kliniske UndersøgelserClinician-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 | Metabolic Arm |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alasdair M Barr, Ph.D. principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Effect of Other Antipsychotics and Neuroleptics, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delrae Fawcett, M.Sc. (604-875-2000 ext. 6115, delrae.fawcett@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.