NCT04599855

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

A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 477 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Depressive Disorder, Treatment-Resistant

Interventions

Type	Name	Description
DRUG	Esketamine 56 mg	Esketamine 56 mg will be self administered as nasal spray.
DRUG	Esketamine 84 mg	Esketamine 84 mg will be self administered as nasal spray.
DRUG	Placebo	Matching placebo will be self administered as nasal spray.

Timeline

• Start date: 2020-11-04
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2020-10-23
• Last updated: 2025-04-25
• Results posted: 2025-03-04

Locations

54 sites across 1 country: United States

Regulatory

• FDA-regulated drug study