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Randomized, controlled, participant- and rater-blind trial of pharmacogenomic test-guided treatment versus treatment as usual for major depressive disorder.

Authors
  • Perlis, Roy H1
  • Dowd, Daniel2
  • Fava, Maurizio1
  • Lencz, Todd3
  • Krause, David S2
  • 1 Department of Psychiatry and Division of Clinical Research, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
  • 2 Clinical Research & Development and Medical Affairs, Genomind, Inc., King of Prussia, Pennsylvania.
  • 3 Department of Psychiatry, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.
Type
Published Article
Journal
Depression and anxiety
Publication Date
Sep 01, 2020
Volume
37
Issue
9
Pages
834–841
Identifiers
DOI: 10.1002/da.23029
PMID: 32383277
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Cohort and cost-effectiveness studies suggest that measuring variation in genes that influence metabolism of common drugs could improve antidepressant treatment outcomes. Prior randomized trials have yielded inconsistent results. Multicenter randomized double-blind (subject and rater), controlled trial of pharmacogenomic testing among outpatients with nonpsychotic major depressive disorder. Study participants (n = 304) were randomized 1:1 to assay-guided treatment (AGT; N = 151) or treatment-as-usual (TAU; N = 153). Participants and raters were blinded to study arm; unblinded clinicians received results of a pharmacogenomic test and adjusted treatment in light of the test report. Primary outcome was change over 8 weeks in Hamilton Depression Rating Scale (SIGH-D-17). For the primary comparison of interest, change in SIGH-D-17, no significant difference was detected between AGT and TAU at Week 8 (p = .53). Rates of study completion also did not differ between the arms (AGT 92.7%, TAU 92.2% (χ2 = 0.03, df = 1, p = .86). Exploratory analyses suggested significantly fewer individuals experienced worsening of depressive symptoms following AGT, and that treatment concordant with assay results was associated with greater likelihood of remission. Pharmacogenomic testing using a panel of pharmacokinetic and pharmacodynamic variants was not associated with significant improvement in the primary efficacy outcome when providers were unconstrained by the assay results. Further investigation is needed to understand the discordance with cost-effectiveness results and among randomized trials. © 2020 Wiley Periodicals, Inc.

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