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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 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. The trial reports 20 study locations across 11 states.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01998958
The ClinicalTrials.gov registry entry for NCT01998958 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 108 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 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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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