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
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 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, Cedarhurst, New York +2 locations
Conditions: Treatment-resistant Depression
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: Clinilabs, New York, New York +2 locations
Conditions: Depressive Disorder, Treatment-Resistant
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:
04/15/2025
Locations: Montefiore Medical Center - Albert Einstein College of Medicine, Bronx, New York +3 locations
Conditions: Chronic Postsurgical Pain
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:
03/27/2025
Locations: Icahn School of Medicine at Mount Sinai, New York, New York
Conditions: Major Depressive Disorder
The Using Postoperative Ketamine and Exploring the Effect on Endometriosis Pain (UPKEEEP) Study
Terminated
This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6 mg/kg) of ketamine versus placebo (saline) on postoperative pain and pain on adult female chronic pelvic pain patients undergoing robotic removal of endometriosis. The objective of the study is to explore the effect of a sub anesthetic dose of ketamine (0.6 mg/kg) vs. saline control on postoperative pain and recovery in chronic pelvic pain patients who have undergone robotic rem... Read More
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
03/10/2025
Locations: NYU Langone Health, New York, New York
Conditions: Endometriosis, Post Operative Pain
Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery
Completed
The purpose of this pilot study was to compare two commonly employed intravenous drug combinations; I) nitrous oxide, midazolam, fentanyl, and ketamine and II) the same combination with substitution of propofol for ketamine, for use during wisdom teeth extraction. Measures of recovery, amnesia testing 20 minutes after induction and after completion of recovery tests, patient satisfaction, and surgeon satisfaction will be evaluated. The data from this pilot study will be used to obtain preliminar... Read More
Gender:
ALL
Ages:
16 years and above
Trial Updated:
03/05/2025
Locations: NYCHHC - Jacobi Medical Center and North Central Bronx Hospital, Bronx, New York
Conditions: Anesthesia, Tooth Extraction
Efficacy of Ketamine for Improvement in Postoperative Pain Control After Spinal Fusion for Idiopathic Scoliosis
Completed
This study hypothesizes that the addition of a low-dose ketamine infusion to usual post-operative pain management will improve pain control as evidenced by an improvement in post-operative pain scores for patients undergoing spinal fusion for idiopathic scoliosis.
Gender:
ALL
Ages:
All
Trial Updated:
02/19/2025
Locations: Albany Medical Center, Albany, New York
Conditions: Idiopathic Scoliosis, Post-operative Pain
Morphine or Ketamine for Analgesia
Not Yet Recruiting
Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative... Read More
Gender:
ALL
Ages:
Between 6 years and 17 years
Trial Updated:
02/17/2025
Locations: NewYork Presbyterian Morgan Stanley Children's Hospital, New York, New York
Conditions: Abdominal Pain, Isolated Extremity Fracture, Pain, Pediatrics
The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
Recruiting
Ketamine is a medication that came into clinical practice in the 1960's. Ketamine is used as an anesthetic and to provide pain relief. Recently, Ketamine was approved to treat drug resistant depression using subanesthetic doses. In the hospital setting, intravenous anesthetic dosages are used to treat unrelenting seizures known as status epilepticus in comatose patients. Ketamine in subanesthetic doses has not been tried as a treatment for medication resistant seizures in the outpatient setting.... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
02/12/2025
Locations: Mount Sinai Hospital, New York, New York
Conditions: Drug Resistant Epilepsy, Medically Refractory Epilepsy, Refractory Epilepsy
Single-dose Ketamine Treatment to Improve Depression in Mild Cognitive Impairment
Active Not Recruiting
Ketamine is a NMDA-receptor antagonist that promotes synapse formation and has been shown to rapidly improve symptoms in depression. Even a single dose of ketamine has been shown to improve depression and cognition with short-term memory, inhibitory control, cognitive flexibility, and processing speed showing improvements within days of treatment. The mechanism behind ketamine's rapid action is not clear but some groups have speculated it may be related to enhanced neuroplasticity, particularly... Read More
Gender:
ALL
Ages:
Between 50 years and 90 years
Trial Updated:
01/27/2025
Locations: Icahn School of Medicine at Mount Sinai (Depression and Anxiety Center), New York, New York
Conditions: Depression, Mild Cognitive Impairment