Treatment Response With Esketamine Nasal Spray Plus an Oral Antidepressant in Patients With Treatment-Resistant Depression Without Evidence of Early Response
Ibrahim Turkoz, Ella Daly, Jaskaran Singh, Xiwu Lin, Yevgen Tymofyeyev, David Williamson, Giacomo Salvadore, Abigail I. Nash, Matthew Macaluso, Samuel T. Wilkinson, J. Craig Nelson
The Journal of Clinical Psychiatry July 16, 2021 DOI: 10.4088/jcp.20m13800 (opens in new tab) via OpenAlex
Summary
AI-generated from the abstractFor patients with treatment-resistant depression who did not show a response within the first week of treatment, a full four-week induction course of esketamine nasal spray plus an oral antidepressant may still provide benefit. In a pooled analysis of two phase 3 trials, among those not meeting early response criteria at day 2 or days 2 and 8, the odds of a response by day 28 were about 1.6 times higher with esketamine plus antidepressant compared to antidepressant plus placebo. The findings suggest that lack of early improvement does not preclude later benefit from the full induction course.
Study at a glance
| Characteristics | Pooled post hoc analysis of two phase 3, double-blind, active-controlled studies Peer reviewed |
|---|---|
| Population | Patients with treatment-resistant depression |
| Duration | 4-week induction course |
| Topics | Anxiety Depression |
| Keywords | Antidepressant Depression economics Nasal spray Anesthesia |
| Citations | 21 |
| Registration | NCT02417064 NCT02418585 |
| Key finding | Patients with treatment-resistant depression who did not respond within the first week of treatment may still benefit from a full 4-week induction course of esketamine nasal spray. |
Abstract
) and treatment-resistant depression (TRD) who did not meet response criteria within the first week of treatment. The current study is a pooled post hoc analysis of two phase 3, double-blind, active-controlled studies, conducted between August 2015 and February 2018, comparing ESK + AD with an oral antidepressant plus placebo (AD + PBO). Early treatment response was defined as a ≥ 50% decrease in Montgomery-Åsberg Depression Rating Scale total score at day 2 or days 2 and 8. Response rates at day 28 were determined among those not meeting early response criteria. = .01). In nonresponders at day 2 and at days 2 and 8, the odds ratio for a response at day 28 was 1.61 (95% CI, 1.09-2.40) with ESK + AD versus 1.56 (95% CI, 1.04-2.35) with AD + PBO. Patients with TRD without a demonstrated response within the first week of treatment may still derive benefit from a full 4-week induction course of esketamine nasal spray. ClinicalTrials.gov identifiers NCT02417064 and NCT02418585.