Skip to content
CompletedPhase 2Results posted

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

NCT02133001 · Janssen Research & Development, LLC

Closed to entry
Status
Not accepting participants
Phase 2
Phase
68
Target enrolment
14
Study sites
11 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change From Baseline to Day 1: 4-Hour Post-dose in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Double-blind Phase)

    Measured over Baseline (Day 1-Predose) to Day 1: 4-hours post-dose

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Participants must meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnostic criteria for major depressive disorder * Participants must have current suicidal ideation with intent * In the Investigator's opinion, participant must be in need of acute psychiatric hospitalization due to imminent risk of suicide * Participant has a Montgomery Asberg Depression Rating Scale (MADRS) total score of greater than or equal to (\>=) 22 predose on Day 1 * As part of standard of care treatment, participant agrees to be hospitalized voluntarily for a recommended period of 5 days after randomization (that is, through Day 5), and take prescribed non-investigational antidepressant therapy(ies) for at least the duration of the double-blind treatment phase (Day 25) Exclusion Criteria: * Participant has a current clinical diagnosis of bipolar or related disorders, intellectual disability, or cluster b personality disorder (example, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, and narcissistic personality disorder) * Participant meets DSM-IV criteria for borderline personality disorder, based on clinical interview * Participant has a current or prior diagnosis of a psychotic disorder, major depressive disorder (MDD) with psychosis, or obsessive compulsive disorder * Participant with a history or current signs and symptoms of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbances * Participant has uncontrolled hypertension (systolic blood pressure greater than \[\>\] 160 millimeter of mercury \[mmHg\] or diastolic blood pressure \> 90 mmHg) despite diet, exercise or a stable dose of an allowed anti-hypertensive treatment at Screening; or any past history of hypertensive crisis

Where

14 study sites

FacilityCityRegionCountry
BirminghamAlabamaUnited States
San DiegoCaliforniaUnited States
HartfordConnecticutUnited States
New HavenConnecticutUnited States
AtlantaGeorgiaUnited States
Iowa CityIowaUnited States
BaltimoreMarylandUnited States
TowsonMarylandUnited States
Ann ArborMichiganUnited States
RochesterMinnesotaUnited States
CincinnatiOhioUnited States
PhiladelphiaPennsylvaniaUnited States
PittsburghPennsylvaniaUnited States
HoustonTexasUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02133001 on ClinicalTrials.gov →

Last updated in the registry 2025-04-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits