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 +5 locations
Conditions: Major Depression Disorder
Ketamine-assisted Therapy for Advanced GI Cancer
Terminated
This clinical trial evaluates whether it is possible to use a single dose of ketamine in combination with talk therapy to treat moderate to severe demoralization in patients with stage 3 or 4 gastrointestinal (GI) cancers who take opioids for cancer-related pain. Advanced stage gastrointestinal (GI) cancer patients often suffer from high rates of psychosocial distress and pain. Symptoms of anxiety are highly prevalent among gastrointestinal (GI) cancers patients. While opioid analgesia (pain rel... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
04/29/2025
Locations: University of California, San Francisco, San Francisco, California
Conditions: Pancreatic Ductal Adenocarcinoma, Pain, Acute, Gastrointestinal Cancers, Demoralization
Evaluating the Neuromodulatory Effect of Ketamine in Long COVID-19
Enrolling By Invitation
Plain Language Summary: This study is a clinical trial to see if ketamine can help treat symptoms of Long COVID, especially fatigue and problems with thinking clearly (often called "brain fog"). Long COVID is a condition that affects people even after they have recovered from COVID-19, causing ongoing health issues like tiredness, memory problems, and difficulty concentrating. Right now, there are very few treatments available for these symptoms, and many people are looking for new options to f... Read More
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
04/29/2025
Locations: UT Health Austin, Austin, Texas
Conditions: Long COVID
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 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
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
A Study to Evaluate the Efficacy, Pharmacokinetics, 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 evaluate the efficacy of switching adult participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to flexibly dosed intranasal esketamine (56 milligram \[mg\] or 84 mg) plus a newly initiated oral antidepressant compared with switching to a newly initiated oral antidepressant (active comparator) plus intranasal placebo, in improving depressive symptoms. Efficacy will be assessed by the change f... Read More
Gender:
ALL
Ages:
Between 18 years and 64 years
Trial Updated:
04/25/2025
Locations: Atlanta Center for Medical Research, Atlanta, Georgia +29 locations
Conditions: Depressive Disorder, Treatment-Resistant
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 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 +4 locations
Conditions: Depression
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
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
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, Birmingham, Alabama +91 locations
Conditions: Treatment-resistant Depression