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NCT02493868 · ClinicalTrials.gov registry record · Phase 3
A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 719
- Enrollment target
NCT02493868: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02493868 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 719 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02493868, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 719 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.
Primary Outcome
Relapse is defined as any of following: Montgomery-asberg depression rating scale (MADRS) total score greater than or equal to (\>=) 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalize
Interventions
- DRUG Placebo
- DRUG Esketamine
- DRUG Duloxetine (Oral Antidepressant)
- DRUG Escitalopram (Oral antidepressant)
- DRUG Sertraline (Oral Antidepressant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 719 participants |
| Start Date | 2015-10-01 |
| Est. Completion | 2018-02-16 |
| Phase | Phase 3 |
What the finished NCT02493868 record still lists
NCT02493868 is an interventional study that assigns participants to a tested intervention. The registered 719 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02493868 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02493868 about?
NCT02493868 is a clinical study titled "A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression". The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in st...
What is the current status of trial NCT02493868?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 719 participants. The study started on 2015-10-01. Estimated completion is 2018-02-16.
What interventions are being tested in trial NCT02493868?
The interventions under investigation include: Placebo (DRUG), Esketamine (DRUG), Duloxetine (Oral Antidepressant) (DRUG), Escitalopram (Oral antidepressant) (DRUG), Sertraline (Oral Antidepressant) (DRUG).
Who is sponsoring clinical trial NCT02493868?
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 NCT02493868's enrollment target sits among peer trials
719 498th of 2000 higher than 1,503 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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