NCT01966588

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 21, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

3.8 years

First QC Date

June 28, 2013

Last Update Submit

May 30, 2016

Conditions

Adverse Effect of Other Antipsychotics and Neuroleptics

Keywords

Antipsychotic agentsAdverse effectsGenomicsTranscriptome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Other Outcomes (2)

  • Number of adverse effects, as rated by the UKU Side Effect Rating Scale.

    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

    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)

Study Arms (2)

Metabolic Arm

Blood samples for whole genomic/transcriptomic sequencing; administration of the UKU Side Effect Rating Scale.

Other: Blood samples for whole genomic/transcriptomic sequencingOther: UKU Side Effect Rating Scale

Neutropenia/Immune System Arm

Blood samples for whole genomic/transcriptomic sequencing

Other: Blood samples for whole genomic/transcriptomic sequencing

Interventions

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.

Metabolic ArmNeutropenia/Immune System Arm
UKU Side Effect Rating ScaleOTHER

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.

Also known as: UKU, Udvalg for Kliniske Undersøgelser
Metabolic Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals taking antipsychotic medications (in- or outpatients)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Mental Health and Addictions Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will be collecting and retaining whole blood samples for genomic testing.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Alasdair M Barr, Ph.D.

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Delrae Fawcett, M.Sc.

CONTACT

604-875-2000delrae.fawcett@ubc.ca

Heidi N Boyda, Ph.D.

CONTACT

604-612-5025hnboyda@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2013

First Posted

October 21, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

CA(1)