Patient preferences for ketamine-based antidepressant treatments in treatment-resistant depression: Results from a clinical trial and panel

Accepted

Journal Article

© 2020 Elsevier GmbH Background: Novel ketamine-based pharmacotherapies can reduce depressive symptoms among patients with treatment-resistant depression (TRD), but associated short-term symptoms and potential adverse events raise complex benefit-risk questions. Methods: A web-based discrete-choice experiment was administered to 161 esketamine-treated TRD subjects participating in the SUSTAIN-2 and SUSTAIN-3 clinical-trials; and to 301 online panel participants. Participants evaluated hypothetical depression treatments defined by varying levels of improvement in depression symptoms; time to response; transient post-dose issues (dissociation, dizziness, monitoring requirements, and driving restrictions); and potential long-term risks of ulcerative cystitis and cognitive impairment previously reported from ketamine abuse. Results: The clinical-trial and panel respondents had similar preferences. On average, the 54 % of clinical-trial and 64 % of panel respondents who accepted benefit-risk tradeoffs placed the highest value on improving depression symptoms (relative importance = 10) and the least importance on avoiding transient post-dose issues (relative importance <3). Clinical-trial respondents were willing to accept risks of permanent cognitive impairment up to 4.7 % [95 % CI: 3.5 % – >5.0 %] or ulcerative cystitis higher than the survey's maximum 5 % level to improve their depression symptoms from MADRS-40 (severe) equivalent to MADRS-20 (moderate) equivalent; panel respondents accepted somewhat lower risks (P>.05). Conclusions: Most patients and panelists indicated a willingness to accept significant ulcerative cystitis or cognitive risks to realize improvements in depression, with few differences between samples. Avoiding transient post-dose issues with esketamine was of relatively little concern to most participants.

Full Text

Duke Authors

Cited Authors

  • Fairchild, AO; Katz, EG; Reed, SD; Johnson, FR; DiBernardo, A; Hough, D; Sing, J; Levitan, B

Published Date

  • September 1, 2020

Published In

Volume / Issue

  • 37 /

Start / End Page

  • 67 - 78

Electronic International Standard Serial Number (EISSN)

  • 2212-8581

International Standard Serial Number (ISSN)

  • 0941-9500

Digital Object Identifier (DOI)

  • 10.1016/j.npbr.2020.05.003

Citation Source

  • Scopus