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 : December 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major||Drug: Esketamine Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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).
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).
Intranasal Placebo solution
- 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.
- 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).
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
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|