The effect of esketamine in patients with treatment-resistant depression with and without comorbid anxiety symptoms or disorder.

Abstract

BACKGROUND:

Comorbid anxiety is generally associated with poorer response to antidepressant treatment. This post hoc analysis explored the efficacy of esketamine plus an antidepressant in patients with treatment-resistant depression (TRD) with or without comorbid anxiety.

METHODS:

TRANSFORM-2, a double-blind, flexible-dose, 4-week study (NCT02418585), randomized adults with TRD to placebo or esketamine nasal spray, each with a newly-initiated oral antidepressant. Comorbid anxiety was defined as clinically noteworthy anxiety symptoms (7-item Generalized Anxiety Disorder scale [GAD-7] score ≥10) at screening and baseline or comorbid anxiety disorder diagnosis at screening. Treatment effect based on change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, and response and remission were examined by presence/absence of comorbid anxiety using analysis of covariance and logistic regression models.

RESULTS:

Approximately 72% (162/223) of patients had baseline comorbid anxiety. Esketamine-treated patients with and without anxiety demonstrated significant reductions in MADRS (mean [SD] change from baseline at day 28: -21.0 [12.51] and -22.7 [11.98], respectively). Higher rates of response and remission, and a significantly greater decrease in MADRS score at day 28 were observed compared to antidepressant/placebo, regardless of comorbid anxiety (with anxiety: difference in LS means [95% CI] -4.2 [-8.1, -0.3]; without anxiety: -7.5 [-13.7, -1.3]). There was no significant interaction of treatment and comorbid anxiety (p = .371). Notably, in the antidepressant/placebo group improvement was similar in those with and without comorbid anxiety.

CONCLUSION:

Post hoc data support efficacy of esketamine plus an oral antidepressant in patients with TRD, regardless of comorbid anxiety.

• Authors: Ella J Daly, Ibrahim Turkoz, Giacomo Salvadore, Maggie Fedgchin, Dawn F Ionescu, H Lynn Starr, Stephane Borentain, Madhukar H Trivedi, Michael E Thase, Jaskaran B Singh
• Journal: Depression and anxiety (Depress Anxiety) Vol. 38 Issue 11 Pg. 1120-1130 (11 2021) ISSN: 1520-6394 [Electronic] United States
• PMID: 34293233 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2021 The Authors. Depression and Anxiety Published by Wiley Periodicals LLC.

Chemical References

• Esketamine
• Ketamine

Topics

• Adult
• Anxiety
• Depression
• Depressive Disorder, Treatment-Resistant (drug therapy, epidemiology)
• Double-Blind Method
• Drug Therapy, Combination
• Humans
• Ketamine
• Treatment Outcome