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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 is a Phase 4 study that has completed, run by Janssen Research & Development. The registered enrollment target is 477 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04599855
The ClinicalTrials.gov registry entry for NCT04599855 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 477 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04599855 reports 0 study locations.
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.
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