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Clinical Trial
. 2023 May:323:115165.
doi: 10.1016/j.psychres.2023.115165. Epub 2023 Mar 16.

Predictors of response and remission in patients with treatment-resistant depression: A post hoc pooled analysis of two acute trials of esketamine nasal spray

Ibrahim Turkoz  1 , J Craig Nelson  2 , Samuel T Wilkinson  3 , Stephane Borentain  4 , Matthew Macaluso  5 , Madhukar H Trivedi  6 , David Williamson  7 , John J Sheehan  8 , Giacomo Salvadore  9 , Jaskaran Singh  10 , Ella Daly  11
Affiliations
Free article
Clinical Trial

Predictors of response and remission in patients with treatment-resistant depression: A post hoc pooled analysis of two acute trials of esketamine nasal spray

Ibrahim Turkoz et al. Psychiatry Res. 2023 May.
Free article

Abstract

This exploratory post hoc analysis of two pooled 4-week, phase 3, double-blind, placebo- and active-controlled studies that compared esketamine nasal spray plus a newly initiated oral antidepressant (ESK+AD; n = 310) with a newly initiated oral AD plus placebo nasal spray (AD+PBO; n = 208) in patients with treatment-resistant depression (TRD) examined baseline patient demographic and psychiatric characteristics as potential predictors of response (≥50% reduction from baseline in Montgomery-Åsberg Depression Rating Scale [MADRS] total score) and remission (MADRS total score ≤12) at day 28. Overall, younger age, any employment, fewer failed ADs in the current depressive episode, and reduction in Clinical Global Impression-Severity (CGI-S) score at day 8 were significant positive predictors of response and remission at day 28. Treatment assignment was an important predictor of both response and remission. Patients treated with ESK+AD had 68% and 55% increased odds of achieving response and remission, respectively, versus those treated with AD+PBO. In the ESK+AD group, attainment of response and remission was more likely in patients who were employed, without significant anxiety at baseline, and who experienced a reduction in CGI-S score at day 8. Identification of predictors of response and remission may facilitate identification of those patients with TRD most likely to benefit from ESK+AD. Trial Registration: ClinicalTrials.gov: NCT02417064 (clinicaltrials.gov/ct2/show/NCT02417064) and NCT02418585 (clinicaltrials.gov/ct2/show/NCT02418585).

Keywords: Antidepressant agents; Depressive disorder, major; Psychopharmacology.

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Conflict of interest statement

Declaration of Competing Interest GS is a stockholder of Johnson & Johnson, Inc. This work was conducted when GS was an employee of Janssen. SB is an employee of Janssen and a stockholder of Johnson & Johnson, Inc. ED is a stockholder of Johnson & Johnson, Inc. This work was conducted when ED was an employee of Janssen. JSh is an employee of Janssen and a stockholder of Johnson & Johnson, Inc. JSi is a stockholder of Neurocrine Biosciences. This work was conducted when JSi was an employee of Janssen and stockholder of Johnson & Johnson. IT is an employee of Janssen and a stockholder of Johnson & Johnson, Inc. DW is a stockholder of Johnson & Johnson, Inc. This work was conducted when DW was an employee of Janssen. MM has conducted clinical trials research as principal investigator for the following pharmaceutical companies over the last 12 months: Boehringer Ingelheim Liva Nova, Merck, Neurocrine, Janssen, Novartis, Otsuka. All clinical trial and study contracts were with, and payments made to, the University of Alabama at Birmingham. MM was a member of the speaker bureau for Janssen Pharmaceuticals from April 2019 through June 2020 (Spravato®/esketamine). JCN has served as an adviser or consultant to Astellas, Axsome, Biohaven, Janssen, Johnson and Johnson, Novartis, Otsuka, Sunovion. MT has received consulting fees from Allergan; Alto Neuroscience Inc.; Applied Clinical Intelligence, LLC; Axsome Therapeutics; Boehringer Ingelheim; Engage Health Media; GreenLight VitalSign6 Inc.; Janssen, Lundbeck Research USA; Merck Sharp & Dohme Corp.; Navitor Pharmaceutical, Inc.; Otsuka; Perception Neuroscience; Pharmerit International; Sage Therapeutics; and Signant Health; research support from the NIMH, NIDA, Patient-Centered Outcomes Research Institute (PCORI), Cancer Prevention Research Institute of Texas (CPRIT); and editorial compensation from the American Psychiatric Association (Deputy Editor for American Journal of Psychiatry) and Oxford University Press. STW has received contract funding from Janssen, Sage Therapeutics, and Oui Therapeutics for the conduct of clinical trials administered through Yale University. He has received consulting fees from Janssen, Biohaven, and Oui Therapeutics.

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