54135419SUI3002: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide

Completed · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.

Key facts

Study ID: NCT03097133
Run by: Janssen Research & Development, LLC
People needed: 230
Starts: 2017-06-15
Expected to finish: 2019-04-11
Last updated by the study team: 2025-04-29

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Psychiatric Interview (MINI)
Participants must have current suicidal ideation with intent, confirmed by a "Yes" response to Question B3 [Think (even momentarily) about harming or of hurting or of injuring yourself: with at least some intent or awareness that you might die as a result; or think about suicide (ie, about killing yourself)?] AND Question B10 [Intend to act on thoughts of killing yourself?] obtained from the MINI
In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to participant's imminent risk of suicide
Participant has a Montgomery Asberg Depression Rating Scale (MADRS) total score of greater than (>) 28 predose on Day 1
As part of standard of care treatment, participant agrees to be hospitalized voluntarily for a recommended period of 14 days after randomization (may be shorter or longer if clinically warranted in the investigator's opinion) and take prescribed non-investigational antidepressant therapy(ies) for at least the duration of the double-blind treatment phase (Day 25)

You may not qualify if…

Participant has a current DSM-5 diagnosis of bipolar (or related disorders), antisocial personality disorder, or obsessive compulsive disorder
Participant currently meets DSM-5 criteria for borderline personality disorder. Note: Participant not meeting full DSM-5 criteria for borderline personality disorder but exhibiting recurrent suicidal gestures, threats, or self-mutilating behaviors should also be excluded
Participant has a current clinical diagnosis of autism, dementia, or intellectual disability
Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features
Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder, (except for nicotine or caffeine), within the 12 months before Screening. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary
Participant has a history or current signs and symptoms of liver or renal insufficiency, clinically significant cardiac (including unstable coronary artery disease and congestive heart failure, tachyarrhythmias and recent myocardial infarction) or vascular, pulmonary, gastrointestinal, endocrine (including uncontrolled hyperthyroidism), neurologic (including current or past history of seizures except uncomplicated childhood febrile seizures with no sequelae), hematologic, rheumatologic, or metabolic (including severe dehydration/ hypovolemia) disease
Participant has known allergies, hypersensitivity, intolerance or contraindications to esketamine or ketamine or its excipients

Where it is running

Sharp Mesa Vista Hospital — San Diego, California, United States
University of Conneticut School of Medicine — Farmington, Connecticut, United States
University of Miami Health System — Miami, Florida, United States
Innovative Clinical Research Inc — North Miami, Florida, United States
University of South Florida — Tampa, Florida, United States
Atlanta Behavioral Research, LLC — Atlanta, Georgia, United States
Memorial Medical Center — Springfield, Illinois, United States
Neuroscience Research Institute — Winfield, Illinois, United States
Lake Charles Clinical Trials — Lake Charles, Louisiana, United States
John Hopkins Hospital — Baltimore, Maryland, United States
Altea Research Institute — Las Vegas, Nevada, United States
The Zucker Hillside Hospital — Glen Oaks, New York, United States
Stony Brook University Medical Center — Stony Brook, New York, United States
University of North Carolina — Chapel Hill, North Carolina, United States
University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience — Cincinnati, Ohio, United States
East Tennessee State University — Johnson City, Tennessee, United States
University of Wisconsin Medical Center — Madison, Wisconsin, United States
Clínica Privada Banfield S.A — Banfield, Argentina
Hospital Fleni — Ciudad de Buenos Aires, Argentina
Sanatorio Prof. Leon S. Morra — Córdoba, Argentina
Clinica Privada de Salud Mental Santa Teresa de Ávila — La Plata, Argentina
Medical University Vienna MUV — Vienna, Austria
Klinikum Wels Grieskirchen — Wels, Austria
AZ Sint Jan Brugge Oostende AV — Bruges, Belgium
University of California San Diego/Psychiatry — San Diego, California, United States

Full record on ClinicalTrials.gov

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