Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression
Recruiting
The proposed study is a single-site, randomized, controlled clinical trial (RCT) comparing ketamine-assisted psychotherapy (KAP) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (KET). Eligible study participants will be adults with major depressive disorder (MDD). Adults with MDD will be randomized to KAP or KET in a 1:1 allocation. Each treatment group will receive KAP or KET over a period of four weeks. Measurement of depression severity,... Read More
Gender:
ALL
Ages:
Between 18 years and 90 years
Trial Updated:
07/10/2025
Locations: Icahn School of Medicine at Mount Sinai, New York, New York
Conditions: Major Depressive Disorder
Glutamatergic Mechanisms of Psychosis and Target Engagement (SA1)
Suspended
50 healthy volunteers (HV) will participate in 2 identical ketamine-induced pharmacoBOLD (phBOLD) sessions at least 7 days apart. On both days, clinical assessments will be performed following removal of the subject from the scanner. HV will be discharged home after clearance by the study physician. This study will assign ketamine doses in successive 10 subject cohorts. The ketamine dose for the 1st cohort will start at 0.08 mg/kg. For subsequent cohorts, the bolus will be successively reduced... Read More
Gender:
ALL
Ages:
Between 18 years and 55 years
Trial Updated:
07/08/2025
Locations: New York State Psychiatric, New York, New York
Conditions: Healthy
Department of Defense PTSD Adaptive Platform Trial - Intervention D - SLS-002
Not Yet Recruiting
This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for Post Traumatic Stress Disorder (PTSD) utilizing an adaptive platform trial (APT) design. Intervention D - SLS-002 will assess the safety and efficacy of SLS-002 in participants with PTSD. Please see NCT05422612 for information on the S-21-02 Master Protocol.
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
07/03/2025
Locations: Upstate Clinical Research Associates, LLC, Williamsville, New York
Conditions: Post Traumatic Stress Disorder
Neural Circuit Effects of Ketamine in Depression
Recruiting
This project is designed to examine the role of the subgenual anterior cingulate cortex (sgACC) in anhedonia and anxiety in humans with depression, as well as the acute and sustained effects of ketamine on agACC activation and depression symptoms.
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
06/30/2025
Locations: Icahn School of Medicine at Mount Sinai, New York, New York
Conditions: Major Depressive Disorder
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
Active Not Recruiting
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours) and continued for 2 hours postoperatively. Participants in the second arm will receive a single dose of 0.6 mg/kg of ketamine in the post-anesthesia care unit, and the final group will serve as the c... Read More
Gender:
FEMALE
Ages:
18 years and above
Trial Updated:
06/24/2025
Locations: Montefiore Medical Center - Albert Einstein College of Medicine, Bronx, New York +3 locations
Conditions: Chronic Postsurgical Pain
Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED
Recruiting
In situations where intravenous access is not readily available or is unobtainable and the intranasal route is not feasible, another non-invasive route of ketamine administration, such as inhalation via breath-actuated Nebulizer (BAN), is becoming a viable alternative. The BAN allows the controlled, patient-initiated delivery of analgesics in a measured and titratable fashion. (18) Ketamine has been studied as a nebulized drug in a lot of different settings and for a lot of different reasons, su... Read More
Gender:
ALL
Ages:
Between 18 years and 120 years
Trial Updated:
05/30/2025
Locations: Maimonides Medical Center, Brooklyn, New York
Conditions: Pain, Acute
IM Ketamine vs Midazolam for Suicidal ER Patients
Suspended
Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. There is no approved treatment for rapid relief of suicidal thoughts although clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with inexpensive, generic, sub-anesthetic ketamine. We propose a clinical trial of intramuscular ketamine in depressed ED patients with... Read More
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
05/09/2025
Locations: Comprehensive Psychiatric Emergency Department of Columbia University Medical Center, New York, New York
Conditions: Depression, Unipolar, Depression, Bipolar, Suicidal Ideation
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: The Medical Research Network, LLC, New York, New York
Conditions: Depressive Disorder, Treatment-Resistant
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 York, New York +1 locations
Conditions: Depressive Disorder, Treatment-Resistant
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, New York, New York
Conditions: Treatment-resistant Depression
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: The Zucker Hillside Hospital, Glen Oaks, New York +1 locations
Conditions: Depressive Disorder, Major
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: State University of New York at Buffalo, Buffalo, New York
Conditions: Depressive Disorder, Major