Enhancing Week-long Psychological Treatment for PTSD With Ketamine
Recruiting
The purpose of this study is to test if the combination of ketamine, vs midazolam, with an intensive trauma-focused psychotherapy will be more effective in relieving post-traumatic stress disorder (PTSD). This week-long treatment has the potential to produce a significant therapeutic effect that otherwise would take months to occur. The study will also focus on learning about the neurophysiological changes produced by the proposed clinical trial.
Gender:
ALL
Ages:
Between 21 years and 70 years
Trial Updated:
05/06/2025
Locations: Yale University School of Medicine, New Haven, Connecticut
Conditions: Posttraumatic Stress Disorder
The OBSERVE Protocol
Recruiting
This observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches. This 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.
Gender:
ALL
Ages:
All
Trial Updated:
05/02/2025
Locations: Mood Institute, Milford, Connecticut +1 locations
Conditions: Major Depression 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:
04/25/2025
Locations: Not set, Hartford, Connecticut
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:
04/25/2025
Locations: University of Conneticut School of Medicine, Farmington, Connecticut
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, Hartford, Connecticut
Conditions: Treatment Resistant Depressive Disorder
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
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: Yale University, New Haven, Connecticut
Conditions: 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: Institute of Living/ Hartford Hospital, Hartford, Connecticut +1 locations
Conditions: Depressive Disorder, Major
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, Hartford, Connecticut +1 locations
Conditions: Major Depressive Disorder
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, Hartford, Connecticut +1 locations
Conditions: Major Depressive Disorder
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, New Haven, Connecticut
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:
04/25/2025
Locations: Not set, Hartford, Connecticut +1 locations
Conditions: Depressive Disorder, Treatment-Resistant