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

NCT04599855 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 477

Last updated 2025-04-25

Study results available
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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

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2024-01-31
Completion
2024-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04599855 on ClinicalTrials.gov