Recruiting

Genomics

Sponsor:

University of British Columbia

Code:

NCT01966588

Conditions

Adverse Effect of Other Antipsychotics and Neuroleptics

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Blood samples for whole genomic/transcriptomic sequencing

UKU Side Effect Rating Scale

Study Details

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.

Conditions

Adverse Effect of Other Antipsychotics and Neuroleptics

Study ID

NCT01966588

Start date

Jun, 2013

Status verified date

May, 2016

Completion date

Mar, 2017

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Metabolic Arm

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

Neutropenia/Immune System Arm

Blood samples for whole genomic/transcriptomic sequencing

Interventions

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.

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.

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) ]

Central Contacts and Locations

Central contacts

Delrae Fawcett, M.Sc.

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

Heidi N Boyda, Ph.D.

604-612-5025hnboyda@gmail.com

Locations

BC Mental Health and Addictions Research Institute

Recruiting

Vancouver, British Columbia, Canada, V5Z 4H4

Contacts

Delrae Fawcett, M.Sc.

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

Heidi N Boyda, Ph.D. (cand)

604-612-5025hnboyda@gmail.com

Principal Investigator:

Alasdair M Barr, Ph.D.

More Information

Sponsor

University of British Columbia

Last update posted

Jun 1, 2016

Last verified

May, 2016

Keywords

  • Antipsychotic agents
  • Adverse effects
  • Genomics
  • Transcriptome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2016-06-01.