A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible 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) subjects 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:
04/25/2025
Locations: Not set, Birmingham, Alabama +50 locations
Conditions: Treatment-resistant Depression
A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression
Completed
The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) 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:
65 years and above
Trial Updated:
04/25/2025
Locations: Not set, San Diego, California +69 locations
Conditions: Depressive Disorder, Treatment-Resistant
A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Participants Who Are 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 along with standard care treatment, in reducing the symptoms of major depressive disorder (MDD) (an affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities, the mood disturbance is prominent and relatively persistent), including the risk for suicide as assessed by the Investigator, in participants who will be assess... Read More
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
04/25/2025
Locations: Not set, Birmingham, Alabama +13 locations
Conditions: Major Depressive Disorder
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:
04/25/2025
Locations: University of California San Diego/Psychiatry, San Diego, California +60 locations
Conditions: Depressive Disorder, Major
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:
04/25/2025
Locations: Not set, Birmingham, Alabama +24 locations
Conditions: Treatment Resistant Depressive Disorder
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine
Completed
The purpose of this study is to evaluate the pharmacokinetics of intranasally administered esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to evaluate the effects of rifampin on the pharmacokinetics of intranasally administered esketamine in healthy Caucasian participants.
Gender:
ALL
Ages:
Between 20 years and 55 years
Trial Updated:
04/25/2025
Locations: Not set, Cypress, California
Conditions: Healthy
Crossover Study to Evaluate the Abuse Potential of Intranasal Esketamine Compared to Racemic Intravenous Ketamine in Nondependent, Recreational Drug Users
Completed
The primary objective of this study is to evaluate the abuse potential of intranasal esketamine (112 milligram and 84 mg) compared to racemic intravenous ketamine (0.5 mg/kg) in nondependent, recreational polydrug users of perception-altering drugs.
Gender:
ALL
Ages:
Between 18 years and 55 years
Trial Updated:
04/25/2025
Locations: Not set, Salt Lake City, Utah
Conditions: Drug Abuse
A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
Completed
The purpose of this open-label, multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression (TRD).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
04/25/2025
Locations: Not set, New Haven, Connecticut +109 locations
Conditions: Treatment-resistant Depression
Ketamine for Methamphetamine Use Disorder
Recruiting
This study aims to determine whether treatment response with IV ketamine is superior to treatment response with IV midazolam in adults with moderate to severe MUD. The study design is a 12-week randomized, double-blind, controlled trial comparing intravenous (IV) ketamine against IV midazolam, delivered over six weeks in 120 adults with moderate to severe methamphetamine use disorder (MUD).
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
04/25/2025
Locations: Interdisciplinary Substance Use and Brain Injury Facility, Albuquerque, New Mexico +3 locations
Conditions: Substance Use Disorders, Substance Use, Methamphetamine Abuse
A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
Completed
The purpose of this study is to evaluate the pharmacokinetics of a single dose of intranasally administered esketamine in participants with impaired renal function when compared to participants with normal renal function.
Gender:
ALL
Ages:
Between 18 years and 70 years
Trial Updated:
04/25/2025
Locations: Not set, Miami, Florida +1 locations
Conditions: Renal Impairment, Healthy
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:
04/25/2025
Locations: Not set, Birmingham, Alabama +176 locations
Conditions: Depressive Disorder, Treatment-Resistant
A Study of Ketamine in Patients With Treatment-resistant Depression
Completed
The purpose of this study is to explore the optimal dose frequency of ketamine in patients with treatment-resistant depression (TRD).
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
04/25/2025
Locations: Not set, Birmingham, Alabama +12 locations
Conditions: Major Depressive Disorder