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
Visit trial
Status Completed
Results Published No
Start date 04 November 2020
End date 31 January 2024
Phase Phase IV
Design Open
Type Interventional
Generation Second
Participants 477
Sex All
Age 18-
Therapy No

Trial Details

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).

NCT Number NCT04599855

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.

Data attribution

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