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 II)

This double-blind, randomized, placebo-controlled trial (n=226) aimed to assess the efficacy and safety of intranasal esketamine 84 milligrams (mg) in addition to comprehensive standard care for rapidly reducing major depressive disorder (MDD) symptoms, including suicidal ideation, in adults at imminent risk for suicide.

Conducted by Janssen Research & Development, LLC, the trial involved a 25-day double-blind treatment phase and a 65-day follow-up phase, with participants evaluated for approximately 13 weeks. The study enrolled participants with MDD who exhibited suicidal ideation, requiring acute psychiatric hospitalization.

The primary outcome measure was the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post the first dose of esketamine.

The trial, designated as Phase III, commenced on June 9, 2017, and completed on December 18, 2018. The enrollment included 226 participants across various locations in the United States and internationally. The study also outlined eligibility criteria for participants, including age range (18 to 64 years), sex, and exclusion criteria related to psychiatric and substance use disorders. Publications regarding study results were not available as of the last update in October 2020.

Topic Depression
Compound Placebo Ketamine
Country United States of America
Visit trial
Status Completed
Results Published Yes
Start date 15 June 2017
End date 11 April 2019
Chance of happening 100%
Phase Phase III
Design Blinded
Type Interventional
Generation Second
Participants 230
Sex All
Age 18- 64
Therapy Yes

Trial Details

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.

NCT Number CT03097133

Sponsors & Collaborators

Johnson & Johnson
One of the largest pharmaceutical companies in the world, Johnson & Johnson are responsible for bringing esketamine to market in the form of Spravato.

Papers

Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II)
This double-blind, placebo-controlled, randomized study (n=230) evaluated esketamine nasal spray (84 mg) for rapid reduction of depressive symptoms in patients with major depressive disorder (MDD) who have active suicide ideation with intent. It found that patients in both treatment categories demonstrated a very significant decrease in depressive symptoms over placebo and confirmed that esketamine nasal spray could play a role in helping critically ill patients with MDD who have suicidal intent.

Data attribution

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