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Characteristics
Randomized controlled trial
Peer reviewed
Population
Adults with treatment-resistant depression
Intervention
Intranasal esketamine
Dose
56 and 84 mg
Duration
4-week trial
Topics
Depression
Esketamine
Key findings
Twice-weekly intranasal esketamine at 56 and 84 mg significantly improved depressive symptoms compared with placebo in adults with treatment-resistant depression.
Abstract
Twice‐weekly dosing of intranasal esketamine resulted in significant improvement in depressive symptoms compared with placebo in adults with treatment‐resistant depression, a 4‐week trial has found. Esketamine doses of 56 and 84 mg both outperformed placebo in the post‐marketing trial. Study results were published online July 2, 2025, in JAMA Psychiatry.
Comparable studies
Other randomized controlled trials on
esketamine for depression , most cited first.
Study
Year
Design
Participants
Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study
Adults with moderate to severe nonpsychotic depression and a history of nonresponse to...
2019
Phase 3, double-blind, active-controlled, multicenter randomized controlled trial
n = 227
Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression
Adults with treatment-resistant depression who achieved stable remission or stable...
2019
Phase 3, multicenter, double-blind, randomized withdrawal study
n = 297
Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression
Adults with DSM-IV-TR diagnosis of major depressive disorder and history of inadequate...
2017
Phase 2, double-blind, doubly randomized, delayed-start, placebo-controlled study
n = 67
Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study
Depressed patients at imminent risk for suicide
2018
Randomized controlled trial
n = 68
Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1)
Adults with moderate-to-severe depression and nonresponse to at least two...
2019
Randomized controlled trial
n = 346
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