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NCT01998958 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression
A Phase 2 study of Treatment Resistant Depressive Disorder, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
- 20
- Study locations
NCT01998958: Completed Phase 2 study of Treatment Resistant Depressive Disorder, sponsored by Janssen Research & Development.
NCT01998958 is a Phase 2 study of Treatment Resistant Depressive Disorder that has completed, run by Janssen Research & Development. The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01998958, a Phase 2 study of Treatment Resistant Depressive Disorder, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and dose response of intranasal esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with placebo in improving depressive symptoms in participants with treatment-resistant depression (TRD).
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Esketamine 56 mg
- DRUG Esketamine 84 mg
- DRUG Esketamine 14 mg
- DRUG Esketamine 28 mg
Study Locations (20)
Other
- - Lede
- - Akita
- - Hiroshima
- - Ichikawa
- - Kanzaki
- - Kashihara
Florida
- - Jacksonville
- - Tampa
Illinois
- - Chicago
- - Hoffman Estates
New York
- - Cedarhurst
- - New York
Pennsylvania
- - Allentown
- - Philadelphia
Alabama
- - Birmingham
California
- - Garden Grove
Connecticut
- - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2014-01-27 |
| Est. Completion | 2015-09-25 |
| Phase | Phase 2 |
What the finished NCT01998958 record still lists
NCT01998958 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Treatment Resistant Depressive Disorder appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01998958 names 20 study sites across 11 states, led by Other, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT01998958 about?
NCT01998958 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression". The purpose of this study is to assess the efficacy and dose response of intranasal esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with placebo in improving depressive symptoms in participants with treatment-resistant depression (TRD).
What is the current status of trial NCT01998958?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2014-01-27. Estimated completion is 2015-09-25.
What conditions does trial NCT01998958 study?
This clinical trial studies the following conditions: Treatment Resistant Depressive Disorder.
What interventions are being tested in trial NCT01998958?
The interventions under investigation include: Placebo (DRUG), Esketamine 56 mg (DRUG), Esketamine 84 mg (DRUG), Esketamine 14 mg (DRUG), Esketamine 28 mg (DRUG).
Who is sponsoring clinical trial NCT01998958?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01998958 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01998958's enrollment target sits among peer trials
108 640th of 2000 higher than 1,355 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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