CompletedPhase 3ketamine
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
Sponsored by Janssen Research & Development, LLC
NCT ID
NCT03039192
Target Enrollment
226 participants
Start Date
2017-06-09
Est. Completion
2018-12-18
About This Study
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.
Conditions Studied
Interventions
- •Esketamine
- •Placebo
- •Standard of Care
Eligibility
Age:18 Years - 64 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study Locations (56)
UAB Department of Psychiatry and Behavioral Neurobiology
Birmingham, Alabama, United States
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
+46 more locations