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NCT04599855 · ClinicalTrials.gov registry record · Phase 4
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
A Phase 4 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 477
- Enrollment target
NCT04599855: Completed Phase 4 study, sponsored by Janssen Research & Development.
NCT04599855 is a Phase 4 study that has completed, run by Janssen Research & Development. The registered enrollment target is 477 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04599855, a Phase 4 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 477 participants
- Enrollment target
Study 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).
Primary Outcome
The MADRS was a clinician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The scale consisted of 10 items, each of which was scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms). MADRS total score was the sum of scores from individual question items, which ranged from 0 to 60, higher scores represented a more severe condition. The MADRS evaluated apparent sadness, reported sadness, inner tension, sleep
Interventions
- DRUG Placebo
- DRUG Esketamine 56 mg
- DRUG Esketamine 84 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 477 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2024-01-31 |
| Phase | Phase 4 |
What the finished NCT04599855 record still lists
NCT04599855 is an interventional study that assigns participants to a tested intervention. The registered 477 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04599855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04599855 about?
NCT04599855 is a clinical study titled "A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression". 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 ...
What is the current status of trial NCT04599855?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 477 participants. The study started on 2020-11-04. Estimated completion is 2024-01-31.
What interventions are being tested in trial NCT04599855?
The interventions under investigation include: Placebo (DRUG), Esketamine 56 mg (DRUG), Esketamine 84 mg (DRUG).
Who is sponsoring clinical trial NCT04599855?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04599855's enrollment target sits among peer trials
477 182nd of 2000 higher than 1,819 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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