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, J. Craig Nelson, Samuel T. Wilkinson, Stephane Borentain, Matthew Macaluso, Madhukar H. Trivedi, David Williamson, John J. Sheehan, Giacomo Salvadore, Jaskaran Singh, Ella Daly
Psychiatry Research March 15, 2023 DOI: 10.1016/j.psychres.2023.115165 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Post hoc analysis of two pooled phase 3 double-blind placebo- and active-controlled trials Peer reviewed |
|---|---|
| Sample size | 518 |
| Population | Patients with treatment-resistant depression |
| Interventions | Esketamine nasal spray newly initiated oral antidepressant placebo nasal spray |
| Duration | 4-week intervention |
| Topics | Anxiety Depression Esketamine |
| Keywords | Post-hoc analysis Placebo Depression economics Clinical global impression Nasal spray Antidepressant Clinical trial Nasal administration Immunology |
| Citations | 19 |
| Registration | NCT02417064 NCT02418585 |
| Key findings | Esketamine nasal spray plus a new oral antidepressant significantly increased odds of response and remission compared to a new oral antidepressant plus placebo nasal spray in treatment-resistant depression. |
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).
In the evidence
This study is part of the evidence base for a synthesis in the library. Here is how each one recorded it.
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Esketamine plus a new oral antidepressant increased odds of response and remission versus antidepressant plus placebo, and response was more likely in patients without significant anxiety at baseline.
Synthesized
Comparable studies
Other randomized controlled trials on esketamine for anxiety, most cited first.