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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 (Aspire I)

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ClinicalTrials.gov Identifier: NCT03039192
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Esketamine Other: Placebo Phase 3

Detailed Description:
This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance which contains no drug) that is compared in a clinical trial with a drug to test if the drug has a real effect), multicenter (when more than one hospital or study team work on a medical research study) study. Study will enroll participants with suicidal ideation who are assessed to be at imminent risk for suicide. The study will consist of a screening evaluation performed within 48 hours prior to the Day 1 intranasal dose immediately followed by a 25-day double-blind treatment phase (Day 1 to 25), and a 65 day follow-up phase (Day 26 to Day 90). The total study duration for each subject will be approximately 13 weeks. Participants' safety will be evaluated throughout the study. If you or a loved one are having thoughts of suicide, please seek immediate medical help. Go to the emergency room or call the National Suicide Prevention Lifeline at 1-800-273-8255.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled 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 Subjects Assessed to be at Imminent Risk for Suicide
Actual Study Start Date : June 9, 2017
Actual Primary Completion Date : December 18, 2018
Actual Study Completion Date : December 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Esketamine
Participants will receive intranasal esketamine 84 milligram (mg) two times per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25).
Drug: Esketamine
Intranasal esketamine solution 84 milligram (mg)

Placebo Comparator: Placebo
Participants will receive intranasal placebo two times per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25).
Other: Placebo
Intranasal Placebo solution




Primary Outcome Measures :
  1. Change From Baseline in MADRS Total Score at 24 Hours Post First Dose [ Time Frame: Baseline, 24 Hours post first dose (Day 2) ]
    The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated scale designed to be used in participants with Major Depressive Disorder (MDD) to measure depression severity and detect changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.


Secondary Outcome Measures :
  1. Change From Baseline in CGI-SS-R at 24 Hours Post First Dose [ Time Frame: Baseline, 24 Hours post first dose (Day 2) ]
    The Clinical Global Impression - Severity of Suicidality - Revised (CGI-SS-R) was derived from the Clinical Global Impression Severity Scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participants illness. The CGI-SS-R rating is scored on a 7-point scale from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal participants).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039192


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Locations
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United States, Alabama
UAB Department of Psychiatry and Behavioral Neurobiology
Birmingham, Alabama, United States, 35294
United States, Arizona
Metropolitan Neuro Behavioral Institute
Chandler, Arizona, United States, 85226
United States, California
Collaborative NeuroScience Network
Garden Grove, California, United States, 92845
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
Alexian Behavioral Health Hospital
Hoffman Estates, Illinois, United States, 60169
United States, Kentucky
University of Louisville, Department of Psychiatry
Louisville, Kentucky, United States, 40202
United States, Louisiana
LSU Health Sciences Center New Orleans
New Orleans, Louisiana, United States, 70115
Louisiana Clinical Research
Shreveport, Louisiana, United States, 71101
United States, Maryland
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21204
CBH Health
Gaithersburg, Maryland, United States, 20877
United States, New York
State University of New York
Buffalo, New York, United States, 14215
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Clinical Trials of America
Hickory, North Carolina, United States, 28601
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Bulgaria
Mental Health Center Prof. Dr. Ivan Temkov
Bourgas, Bulgaria, 8001
Regional Psychiatric Dispansery
Bulgaria, Bulgaria, 7003
State Psychiatric Hospital - Lovech
Lovech, Bulgaria, 5500
UMHAT 'Sveti Georgi'-Plovdiv
Plovdiv, Bulgaria, 4002
Military Medical Academy, Multiprofile Hospital for Active Treatment -Sofia
Sofia, Bulgaria, 1606
Estonia
North Estonian Medical Centre Foundation
Tallinn, Estonia, 10614
Tartu University Hospital
Tartu, Estonia, 50417
Germany
Vivantes Humboldt Klinikum
Berlin, Germany, 13509
Universitatsklinikum Frankfurt
Frankfurt am Main, Germany, 60528
Klinik für Psychiatrie und Psychotherapie
Freiburg, Germany, 79104
Hungary
Semmelweis Egyetem Kútvölgyi Klinikai Tömb
Budapest, Hungary, 1125
Szent János Kórház és Észak-budai Egyesített Kórházak
Budapest, Hungary, 1125
Nyírő Gyula Kórház
Budapest, Hungary, 1135
Petz Aladar Megyei Oktato Korhaz
Győr, Hungary, H-9024
Pécsi Tudományegyetem Klinikai Központ
Pécs, Hungary, 7623
Korea, Republic of
Korea University Ansan Hospital
Ansan-si, Korea, Republic of, 15355
Chonnam National University Hospital
Gwangju-si, Korea, Republic of, 61469
Kyung Hee University Medical Center
Seoul, Korea, Republic of, 02447
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Malaysia
University Kebangsaan Malaysia Medical Centre
Cheras, Malaysia, 56000
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Hospital Tuanku Jaafar
Seremban, Malaysia, 70300
Slovakia
Fakultna nemocnica s poliklinikou v Ziline
Zilina, Slovakia, 012 07
South Africa
Flexivest 14 Research
Cape Town, South Africa, 7550
Juan Schrönen - Western Cape South Africa
Welgemoed, South Africa, 7530
Spain
Hosp. Univ. Fundacion Alcorcon
Alcorcón, Spain, 28922
Hosp. Univ. Vall D Hebron
Barcelona, Spain, 08035
Hosp. Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Inst. Internac. Neurociencias Aplicadas
Barcelona, Spain, 8006
Hosp. Univ. de Basurto
Bilbao, Spain, 48013
Hosp. Univ. Ramon Y Cajal
Madrid, Spain, 28034
Clinica Univ. de Navarra
Pamplona, Spain, 31008
Benito Menni Comp. Asist. Salut Mental
Sant Boi de Llobregat, Spain, 08830
Taiwan
Tri-Service Genaral Hospital
Neihu District, Taiwan, 114
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan, 23561
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03039192     History of Changes
Other Study ID Numbers: CR108284
2016-003990-17 ( EudraCT Number )
54135419SUI3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Suicide
Suicidal Ideation
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Self-Injurious Behavior
Esketamine
Antidepressive Agents
Psychotropic Drugs