A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
Completed
The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
03/29/2025
Locations: Not set, Bradenton, Florida +2 locations
Conditions: Treatment-resistant Depression
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
A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
Completed
The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
03/29/2025
Locations: Not set, Gainesville, Florida +2 locations
Conditions: Depressive Disorder, Treatment-Resistant
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