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NCT02422186 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 139
- Enrollment target
NCT02422186: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT02422186 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 139 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02422186, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 139 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) 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
The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items (to evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel \[interest level\], pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible sco
Interventions
- DRUG Placebo
- DRUG Esketamine
- DRUG Duloxetine (Oral Antidepressant)
- DRUG Escitalopram (Oral Antidepressant)
- DRUG Sertraline (Oral Antidepressant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2015-08-20 |
| Est. Completion | 2017-08-10 |
| Phase | Phase 3 |
What the finished NCT02422186 record still lists
NCT02422186 is an interventional study that assigns participants to a tested intervention. The registered 139 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 (82% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02422186 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02422186 about?
NCT02422186 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression". The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) 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 o...
What is the current status of trial NCT02422186?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 139 participants. The study started on 2015-08-20. Estimated completion is 2017-08-10.
What interventions are being tested in trial NCT02422186?
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 NCT02422186?
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 NCT02422186's enrollment target sits among peer trials
139 1577th of 2000 higher than 424 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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