A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression
Completed
The purpose of this study is to assess the efficacy and dose response of intranasal esketamine (Panel A: 28 mg, 56 mg, and 84 mg and Panel B: 14 mg and 56 mg) compared with placebo in improving depressive symptoms in participants with treatment-resistant depression (TRD).
Gender:
ALL
Ages:
Between 20 years and 64 years
Trial Updated:
03/29/2025
Locations: Not set, Jacksonville, Florida +1 locations
Conditions: Treatment Resistant Depressive Disorder
A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression
Completed
The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
03/29/2025
Locations: Not set, Bradenton, Florida +4 locations
Conditions: Depressive Disorder, Treatment-Resistant
54135419SUI3002: 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
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.
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
03/29/2025
Locations: University of Miami Health System, Miami, Florida +2 locations
Conditions: Depressive Disorder, Major
A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression
Completed
The purpose of this study is to evaluate the efficacy of each individual dose of esketamine nasal spray, 56 milligram (mg) and 84 mg, compared with placebo nasal spray in improving depressive symptoms in participants with treatment resistant depression (TRD), as assessed by the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from Day 1 (prerandomization) to the end of the 4 week double-blind treatment phase (Day 28).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
03/27/2025
Locations: Velocity Clinical Research, Hallandale Beach, Hallandale Beach, Florida +4 locations
Conditions: Depressive Disorder, Treatment-Resistant