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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 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 719 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02493868
The ClinicalTrials.gov registry entry for NCT02493868 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 719 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 5 interventions - of which Placebo is the first listed.
NCT02493868 reports 0 study locations.
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.
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