54135419SUI3001: 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 the 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

NCT03039192

Run by

Janssen Research & Development, LLC

People needed

226

Starts

2017-06-09

Expected to finish

2018-12-18

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)
• In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to participant's imminent risk of suicide
• 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. Note: the response to B3 must refer to the present, whereas the response to B10 may reflect the past 24 hours. If the screening period is longer than 24 hours, assessment of B3 and B10 of MINI must be repeated prior to randomization to confirm eligibility
• 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 5 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)
• Participant is comfortable with self-administration of intranasal medication and able to follow instructions provided

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. 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 6 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

Where it is running

• Metropolitan Neuro Behavioral Institute — Chandler, Arizona, United States
• Collaborative NeuroScience Network — Garden Grove, California, United States
• Yale University — New Haven, Connecticut, United States
• Rush University — Chicago, Illinois, United States
• Alexian Behavioral Health Hospital — Hoffman Estates, Illinois, United States
• University of Louisville Department of Psychiatry — Louisville, Kentucky, United States
• LSU Health Sciences Center New Orleans — New Orleans, Louisiana, United States
• Louisiana Clinical Research — Shreveport, Louisiana, United States
• Sheppard Pratt Health System — Baltimore, Maryland, United States
• CBH Health — Gaithersburg, Maryland, United States
• State University of New York — Buffalo, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Clinical Trials of America — Hickory, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Regional Psychiatric Dispansery — Bulgaria, Bulgaria
• Mental Health Center Prof. Dr. Ivan Temkov — Burgas, Bulgaria
• State Psychiatric Hospital - Lovech — Lovech, Bulgaria
• UMHAT 'Sveti Georgi'-Plovdiv — Plovdiv, Bulgaria
• Military Medical Academy Multiprofile Hospital for Active Treatment Sofia — Sofia, Bulgaria
• North Estonian Medical Centre Foundation — Tallinn, Estonia
• Tartu University Hospital — Tartu, Estonia
• Vivantes Humboldt Klinikum — Berlin, Germany
• UAB Department of Psychiatry and Behavioral Neurobiology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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