Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Recruiting
Background: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect. Objective: Main Study: To study the effects of ketamine in treating depression. Ketamine Metabolites Substudy: To study how ketamine effects brain chemistry. To study how ketamine effects the brain. This... Read More
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
04/04/2025
Locations: National Institutes of Health Clinical Center, Bethesda, Maryland
Conditions: Healthy Volunteer, Major Depressive Disorder, Depression
Prehospital Analgesia INtervention Trial (PAIN)
Recruiting
The Prehospital Analgesia INtervention trial (PAIN) is a proposed 4 year (3-year enrollment) multicenter, prehospital, randomized, double-blind, clinical trial that will enroll approximately 994 patients at select LITES Network sites. The objective is to perform a prospective, interventional, randomized trial among prehospital trauma patients with compensated shock (SI≥0.9) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
04/02/2025
Locations: University of California, San Diego, San Diego, California +8 locations
Conditions: Traumatic Injury
The Dreamy Jet Study
Not Yet Recruiting
The goal of this clinical trial is to see if a device known as a jet-injection system can help deliver a single dose of a sedating medication with less pain and stress than current methods. Participants will receive a dose of the sedative in their arm or thigh before their procedure at the sedation clinic.
Gender:
ALL
Ages:
Between 2 years and 15 years
Trial Updated:
04/02/2025
Locations: University of Wisconsin - Madison, Madison, Wisconsin
Conditions: Sedation, Blood Drawing Procedure, Immunization, IV Placement
Ketamine-Assisted Recovery for Methamphetamine Use Disorder & HIV
Recruiting
The goal of this clinical trial is to learn whether it is possible to use intramuscular (IM) ketamine in combination with psychotherapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in publicly insured patients with or at-risk for HIV disease. The main questions it aims to answer are: * Do publicly insured patients find ketamine-assisted psychotherapy feasible and acceptable as a potential treatment for MeUD? * Is IM ketamine safe and tolerable among patients with MeUD? Parti... Read More
Gender:
ALL
Ages:
Between 18 years and 69 years
Trial Updated:
04/01/2025
Locations: San Francisco Department of Public Health, San Francicso, California
Conditions: Methamphetamine Use Disorder
Randomized Trial of Sedative Choice for Intubation
Recruiting
Among critically ill adults undergoing emergency tracheal intubation, one in five experience hypotension, cardiac arrest, or death. The sedatives used to rapidly induce anesthesia for emergency tracheal intubation have been hypothesized to effect cardiovascular complications and patient outcomes, but the optimal sedative medication for intubation of critically ill adults remains unknown. Ketamine and etomidate are the two most commonly used sedatives during intubation of critically ill adults. D... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
03/31/2025
Locations: UAB Hospital, Birmingham, Alabama +5 locations
Conditions: Acute Respiratory Failure
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:
03/29/2025
Locations: Not set, Birmingham, Alabama +13 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:
03/29/2025
Locations: Not set, San Diego, California +69 locations
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:
03/29/2025
Locations: University of California San Diego/Psychiatry, San Diego, California +60 locations
Conditions: Depressive Disorder, Major
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:
03/29/2025
Locations: Not set, Miami, Florida +1 locations
Conditions: Renal Impairment, Healthy
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:
03/29/2025
Locations: Institute of Living/ Hartford Hospital, Hartford, Connecticut +50 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:
03/29/2025
Locations: Not set, Birmingham, Alabama +24 locations
Conditions: Treatment Resistant Depressive 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:
03/29/2025
Locations: Not set, Birmingham, Alabama +159 locations
Conditions: Depressive Disorder, Treatment-Resistant