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, Cincinnati, Ohio
Conditions: Major Depressive Disorder
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
Completed
The purpose of the 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: The Ohio State University, Columbus, Ohio
Conditions: Depressive Disorder, Major
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 Cincinnati, Dept of Psychiatry & Behavioral Neuroscience, Cincinnati, Ohio
Conditions: Depressive Disorder, Major
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:
04/25/2025
Locations: Not set, Dayton, Ohio
Conditions: Treatment-resistant Depression
A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression
Withdrawn
The purpose of this study is to explore feasibility of combining clinician-directed cognitive behavioral therapy (CBT) supplemented with the Mindset app with esketamine therapy in participants with Treatment-resistant Depression.
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
04/25/2025
Locations: University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience, Cincinnati, Ohio
Conditions: 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, Cincinnati, Ohio
Conditions: Depressive Disorder, Treatment-Resistant
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, Cincinnati, Ohio
Conditions: Treatment-resistant Depression
Study to Evaluate the Efficacy and Safety of 3 Fixed Doses 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 Pediatric Participants Assessed to be at Imminent Risk for Suicide
Completed
The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.
Gender:
ALL
Ages:
Between 9 years and 17 years
Trial Updated:
04/25/2025
Locations: University of Cincinnati Hospital, Cincinnati, Ohio +2 locations
Conditions: Depressive Disorder, Major
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, Cincinnati, Ohio
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:
04/24/2025
Locations: Ohio State University, Columbus, Ohio +1 locations
Conditions: Depressive Disorder, Treatment-Resistant
FMRI of Patients Receiving IV Ketamine for Treatment Resistant Bipolar Depression
Recruiting
This is a prospective open-label observational study of patients with treatment resistant bipolar depression referred for intravenous ketamine, with an interventional component of fMRI.
Gender:
ALL
Ages:
Between 18 years and 75 years
Trial Updated:
04/17/2025
Locations: Cleveland Clinic Lutheran Hospital, Cleveland, Ohio +1 locations
Conditions: Bipolar Depression, Treatment Resistant Bipolar Depression
Ketamine Treatment of Youth Suicide Attempters
Recruiting
Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. In the last decade there is an alarming increase of the number of suicide attempts in patients ages 14-30. Suicide is the second leading cause of death in this population. Patients with previous history of suicide attempt, are even in a higher ris... Read More
Gender:
ALL
Ages:
Between 14 years and 30 years
Trial Updated:
04/15/2025
Locations: The Cleveland Clinic, Cleveland, Ohio
Conditions: Suicide, Attempted