Pharmacogenomic Decision Support With GeneSight Psychotropic to Guide the Treatment With Antipsychotics

NACompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

July 31, 2019

Study Completion Date

September 30, 2020

Conditions
SchizophreniaSchizoaffective Disorder
Interventions
GENETIC

GeneSight Psychotropic (GEN)

Patient DNA will be collected for all subjects and measured for variations in drug target genes and in drug metabolizing genes.Recommendations for optimal choices and dose adjustments for the 33 most commonly prescribed antidepressant and antipsychotic medications will be provided to subjects randomized to the GEN arm. This pharmacogenomic-based interpretive report will be provided to treating clinicians of patients in the GEN arm of the study, allowing clinicians to use the report to support their treatment decisions.

GENETIC

Enhanced-GeneSight Psychotropic (E-GEN)

The E-GEN test incorporates into the existing GEN product new markers that are predictive of side effect of antipsychotic-induced weight gain (AIWG). The pharmacogenomic-based interpretive report from E-GEN will be provided to treating clinicians of patients in the E-GEN arm of the study, allowing clinicians to use the report to support their treatment decisions.

OTHER

Treatment as Usual (TAU)

Subjects randomized to the TAU arm will also require collection of patient DNA. A pharmacogenomic-based interpretive report will be generated from GEN, however, this report is not provided to the treating clinician until completion of the study.

Trial Locations (1)

M6J 1H4

Centre for Addiction and Mental Health, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Programs for Assessment of Technology in Health Research Institute

OTHER

collaborator

Centre for Addiction and Mental Health

OTHER

collaborator

Genome Canada

OTHER

collaborator

AssureRx Canada Ltd

OTHER

collaborator

Assurex Health Inc.

INDUSTRY

collaborator

Mars Excellence in Clinical Innovation and Technology Evaluation

OTHER

lead

St. Joseph's Healthcare Hamilton

OTHER