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NCT02133001 · ClinicalTrials.gov registry record · Phase 2

A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are Assessed to be at Imminent Risk for Suicide

A Phase 2 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 2
Development phase
68
Enrollment target

NCT02133001 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 68 participants.

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The verdict

NCT02133001, a Phase 2 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 2
Development phase
68 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo along with standard care treatment, in reducing the symptoms of major depressive disorder (MDD) (an affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities, the mood disturbance is prominent and relatively persistent), including the risk for suicide as assessed by the Investigator, in participants who will be assessed to be at imminent risk for suicide.

Interventions

  • DRUG Placebo
  • DRUG Esketamine

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2014-05-23
Est. Completion 2016-02-01
Phase Phase 2

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT02133001

The ClinicalTrials.gov registry entry for NCT02133001 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 68 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 2 interventions - of which Placebo is the first listed.

NCT02133001 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02133001 about?

NCT02133001 is a clinical study titled "A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are Assessed to be at Imminent Risk for Suicide". The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo along with standard care treatment, in reducing the symptoms of major depressive disorder (MDD) (an affective disorder manifested by either a dysphoric mood or loss of in...

What is the current status of trial NCT02133001?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2014-05-23. Estimated completion is 2016-02-01.

What interventions are being tested in trial NCT02133001?

The interventions under investigation include: Placebo (DRUG), Esketamine (DRUG).

Who is sponsoring clinical trial NCT02133001?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.