Pharmacogenomic Decision Support With GeneSight Psychotropic to Guide the Treatment of Major Depressive Disorder

Summary

Evidence exists supporting the ability of genetic variations to influence patient drug response and side effects. Previous studies utilizing an open-label design have shown significant improvement in major depressive disorder (MDD) patient outcomes following use of the GeneSight Psychotropic (GEN) test. The first objective of this trial is to utilize a double-blinded, randomized clinical trial design to replicate previous findings of improvement in clinical outcomes in MDD subjects whose medication therapy was guided by GEN testing. Another objective is to determine the added benefit of Enhanced-GeneSight (E-GEN) compared to GEN for the pharmacogenomic guidance of treatment selections. Furthermore, this trial intends to develop an evidence-based case for the value of GEN and E-GEN to Canadian healthcare payers.

Conditions

• Depressive Disorder, Major
• Depression
• Depressive 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.

Sponsors & Collaborators

• Programs for Assessment of Technology in Health Research Institute

  collaborator OTHER

• Centre for Addiction and Mental Health

  collaborator OTHER

• Genome Canada

  collaborator OTHER

• Assurex Health Ltd.

  collaborator UNKNOWN

• Mars Excellence in Clinical Innovation and Technology Evaluation

  collaborator OTHER

• Assurex Health Inc.

  lead INDUSTRY

Principal Investigators

• James L Kennedy, MD · Centre for Addiction and Mental Health

• Bryan Dechairo, PhD · Assurex Health Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2018-11-30

Completion

2019-09-30

Countries

• Canada

Study Locations