A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

Summary

The purpose of this study is to evaluate the efficacy of each individual dose of esketamine nasal spray, 56 milligram (mg) and 84 mg, compared with placebo nasal spray in improving depressive symptoms in participants with treatment resistant depression (TRD), as assessed by the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from Day 1 (prerandomization) to the end of the 4 week double-blind treatment phase (Day 28).

Timeline

Start

2020-11-04

Primary completion

2024-01-31

Completion

2024-01-31

Outcome

Met primary endpoint

registry analysis (superiority test); DB: Placebo vs DB: Esketamine 56 mg; p <0.001; least square (LS) means difference -5.1 (95% CI -7.91 to -2.33); Mixed model for repeated measures NCT04599855 ↗

registry analysis (superiority test); DB: Placebo vs DB: Esketamine 84 mg; p <0.001; LS means difference -6.8 (95% CI -9.48 to -4.07); Mixed model for repeated measures NCT04599855 ↗

Publications

• Janik A, Qiu X, Lane R, Popova V, Drevets WC, Canuso CM, Macaluso M, Mattingly GW, Shelton RC, Zajecka JM, Fu DJ. Esketamine Monotherapy in Adults With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Sep 1;82(9):877-887. doi: 10.1001/jamapsychiatry.2025.1317.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esketamine	Other / unclassified	56 mg	Intranasal
Subject	Esketamine	Other / unclassified	84 mg	Intranasal

Indications