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

This Phase IV double-blind, multicentre, placebo-controlled trial (n=477) aimed to assess the efficacy, safety, and tolerability of esketamine nasal spray (Spravato) as monotherapy in adult participants with treatment-resistant depression (TRD).

Conducted by Janssen Research & Development, LLC, the study evaluated the effectiveness of two individual doses of esketamine nasal spray, 56 mg and 84 mg, compared to placebo nasal spray in improving depressive symptoms.

The primary outcome measure was the change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to the end of the 4-week double-blind treatment phase.

Participants aged 18 and older were eligible if they met DSM-5 diagnostic criteria for TRD and had documented nonresponse to at least two oral antidepressant treatments. The study involved various locations across the United States and commenced in November 2020, with primary completion in January 2024.

Topic Treatment-Resistant Depression Depression
Compound Ketamine Placebo
Country United States of America
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Trial Details



Trial Number

Sponsors & Collaborators

Johnson & Johnson
One of the largest pharmaceutical companies in the world, Johnson & Johnson are responsible for bringing esketamine to market in the form of Spravato.

Papers

Esketamine Monotherapy in Adults With Treatment-Resistant Depression: A Randomized Clinical Trial
This Phase IV randomized controlled trial (n=378) found that esketamine nasal spray (Spravato) monotherapy at both 56mg and 84mg doses significantly reduced depression scores compared to placebo in treatment-resistant depression (TRD) patients at 28 days, with rapid onset of effect observed within 24 hours and moderate effect sizes of 0.48 and 0.63 respectively.

Data attribution

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