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NCT02418585 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 236
- Enrollment target
NCT02418585 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 236 participants.
The verdict
NCT02418585, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 236 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) subjects from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.
Interventions
- DRUG Placebo
- DRUG Esketamine
- DRUG Duloxetine (Oral Antidepressant)
- DRUG Escitalopram (Oral antidepressant)
- DRUG Sertraline (Oral Antidepressant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2015-08-07 |
| Est. Completion | 2017-11-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02418585
The ClinicalTrials.gov registry entry for NCT02418585 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 236 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.
NCT02418585 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02418585 about?
NCT02418585 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression". The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) subjects from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant...
What is the current status of trial NCT02418585?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 236 participants. The study started on 2015-08-07. Estimated completion is 2017-11-06.
What interventions are being tested in trial NCT02418585?
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 NCT02418585?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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