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NCT02417064 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed 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
- 346
- Enrollment target
NCT02417064: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02417064 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 346 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02417064, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 346 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants 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.
Primary Outcome
MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent mor
Interventions
- DRUG Placebo
- DRUG Esketamine
- DRUG Duloxetine (Oral Antidepressant)
- DRUG Escitalopram (Oral antidepressant)
- DRUG Sertraline (Oral Antidepressant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 346 participants |
| Start Date | 2015-08-10 |
| Est. Completion | 2018-02-20 |
| Phase | Phase 3 |
What the finished NCT02417064 record still lists
NCT02417064 is an interventional study that assigns participants to a tested intervention. The registered 346 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02417064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02417064 about?
NCT02417064 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed 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) participants 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 antidepres...
What is the current status of trial NCT02417064?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 346 participants. The study started on 2015-08-10. Estimated completion is 2018-02-20.
What interventions are being tested in trial NCT02417064?
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 NCT02417064?
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 NCT02417064's enrollment target sits among peer trials
346 1049th of 2000 higher than 951 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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