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Esketamine

Generic Name
Esketamine
Brand Names
Spravato
Drug Type
Small Molecule
Chemical Formula
C13H16ClNO
CAS Number
33643-46-8
Unique Ingredient Identifier
50LFG02TXD
Background

Major depressive disorder (MDD) is a significant cause of disability worldwide and the most common illness preceding suicide. On March 5, 2019, the nasal spray drug, esketamine, also known as Spravato (by Janssen Pharmaceuticals), was approved by the FDA for treatment-resistant major depression.

Esketamine is the s-enantiomer of Ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). This is the first time that the FDA has approved esketamine for any use. The FDA approved ketamine (Ketalar) in 1970.

Esketamine may prove to be a promising treatment for patients diagnosed with major depressive disorder who have not experienced an improvement in symptoms despite treatment with various medications and therapies. The intranasal route of administration for this drug allows for easy administration and a fast onset of action, which sets it apart from many other antidepressant agents that may take several weeks to take effect.

Indication

Esketamine is indicated in combination with an oral antidepressant for the treatment of treatment-resistant depression in adults. It is also indicated for the treatment of depressive symptoms in adults with major depressive disorder experiencing acute suicidal ideation or behaviour.

Associated Conditions
Major Depressive Disorder (MDD), Major depressive disorder, recurrent episode, Pain
Associated Therapies
Intubation

The OBSERVE Protocol

Recruiting
Conditions
Major Depression Disorder
Interventions
First Posted Date
2024-12-10
Last Posted Date
2025-05-06
Lead Sponsor
Yale University
Target Recruit Count
450
Registration Number
NCT06725277
Locations
🇺🇸

Emory University, Atlanta, Georgia, United States

🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

🇺🇸

Mood Institute, Milford, Connecticut, United States

and more 3 locations

PCORI Comparative Effectiveness Study-Esketamine (Spravato) vs. Ketamine-Equivalence Study

Phase 3
Recruiting
Conditions
Depression
Interventions
First Posted Date
2024-12-03
Last Posted Date
2025-05-20
Lead Sponsor
Yale University
Target Recruit Count
400
Registration Number
NCT06713616
Locations
🇺🇸

Emory University, Atlanta, Georgia, United States

🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

🇺🇸

Mood Institute, Milford, Connecticut, United States

and more 3 locations

Esketamine for Prevention of Depression After Cytoreductive Surgery in Ovarian Cancer

Not Applicable
Recruiting
Conditions
Ovarian Cancer
Cytoreductive Surgery
Depressive Symptom
Interventions
Drug: placebo
First Posted Date
2024-10-03
Last Posted Date
2025-01-27
Lead Sponsor
Zhejiang Cancer Hospital
Target Recruit Count
568
Registration Number
NCT06624878
Locations
🇨🇳

Zhejiang cancer hospital, Hangzhou, Zhejiang, China

The Impact of Low-Dose Esketamine Combined With Ciprofol on the Quality of Early Postoperative Recovery Among Elderly Patients Undergoing Painless Gastroscopy

Not Applicable
Active, not recruiting
Conditions
Quality of Postoperative Recovery
Interventions
First Posted Date
2024-09-27
Last Posted Date
2025-05-07
Lead Sponsor
Northern Jiangsu People's Hospital
Target Recruit Count
376
Registration Number
NCT06617039
Locations
🇨🇳

Subei People's Hospital of Jiangsu Province, Yangzhou, Jiangsu, China

Different Doses of Dexmedetomidine Combined With Esketamine in Women Undergoing Cesarean Delivery

First Posted Date
2024-09-25
Last Posted Date
2024-12-30
Lead Sponsor
Not specified
Target Recruit Count
120
Registration Number
NCT06613243

Effect of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery

Not Applicable
Recruiting
Conditions
Depression, Anxiety
Cardiac Surgery
S-ketamine
Interventions
Drug: normal saline
First Posted Date
2024-09-23
Last Posted Date
2024-12-31
Lead Sponsor
Chinese PLA General Hospital
Target Recruit Count
142
Registration Number
NCT06608030
Locations
🇨🇳

Beijing Tiantan Hospital, Bejing, Beijing, China

🇨🇳

First Medical center of Chinese PLA General Hospital, Beijing, Beijing, China

Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy

Phase 4
Recruiting
Conditions
Behavior Problem
Interventions
First Posted Date
2024-08-30
Last Posted Date
2024-10-01
Lead Sponsor
Fujian Provincial Hospital
Target Recruit Count
172
Registration Number
NCT06579937
Locations
🇨🇳

Fujian Provincial Hospital, Fuzhou, Fujian, China

Dexmedetomidine-esketamine Combined Nasal Administration and Emergence Delirium

Phase 4
Not yet recruiting
Conditions
Nasal Administration
Esketamine
General Anesthesia
Dexmedetomidine
Older Patients
Emergence Delirium
Interventions
First Posted Date
2024-08-22
Last Posted Date
2024-08-22
Lead Sponsor
Peking University First Hospital
Target Recruit Count
340
Registration Number
NCT06566469
Locations
🇨🇳

Peking University First Hospital, Beijing, Beijing, China

The Effect of Subclinical Dose of Ketamine on Early Postoperative Pain Sensitivity in Patients Undergoing Salpingectomy

Early Phase 1
Not yet recruiting
Conditions
Ectopic Pregnancy
Interventions
First Posted Date
2024-08-19
Last Posted Date
2024-08-19
Lead Sponsor
Fujian Provincial Hospital
Target Recruit Count
60
Registration Number
NCT06559280

Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease

Not Applicable
Recruiting
Conditions
PD - Parkinson's Disease
Esketamine
Deep Brain Stimulation
Interventions
Drug: normal Saline
First Posted Date
2024-08-09
Last Posted Date
2024-08-09
Lead Sponsor
Beijing Tiantan Hospital
Target Recruit Count
102
Registration Number
NCT06543563
Locations
🇨🇳

Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China

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