Comparative Effectiveness of Pharmacogenomics for Treatment of Depression

Summary

The overall goal of this study is to assess the effectiveness of a widely available and widely used combinatorial pharmacogenomic (PGx) test for the treatment of major depressive disorder. Pharmacogenomic tests use genetic information to guide medication treatment decisions. The tests inform clinicians and patients of potential gene-drug interactions by analyzing pharmacokinetic (PK) genes (how drugs are metabolized) as well as pharmacodynamic (PD) genes (how drugs work). While combinatorial PGx testing is attractive to clinicians, patients, healthcare systems, and insurers, limited data demonstrate that PGx testing will result in better outcomes compared to evidence-based guideline treatment. Therefore, the investigators will conduct a prospective randomized comparative effectiveness study of best practice guidelines plus combinatorial PGx-guided treatment versus best-practice guideline concordant treatment alone.

Conditions

• Major Depressive Disorder

Interventions

OTHER

GeneSight Psychotropic test

GeneSight® Psychotropic powered by CPGx® technology, the only test for depression reimbursable by Medicaid and Medicare. GeneSight® is a neuropsychiatric, combinatorial, PGx test that provides recommendations for psychotropic medications (antidepressants, mood stabilizers, hypnotics for insomnia, and antipsychotics) based on a patient's individual genetic profile.

OTHER

Canadian Network for Mood and Anxiety Treatment (CANMAT) Best Practice Guidelines

Guidelines for treatment

Sponsors & Collaborators

• Genetic Alliance

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Montefiore Medical Center

  collaborator OTHER

• Louisiana State University Health Sciences Center in New Orleans

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-01

Primary Completion

2021-03-10

Completion

2022-03-15

Countries

• United States

Study Locations