Esketamine: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Esketamine appears in the FDA drug-label database. Marketed as Spravato.
- Boxed warning
- The FDA label for Esketamine carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
SPRAVATO is indicated for the treatment of: Treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant SPRAVATO is a non-competitive N -methyl D -aspartate (NMDA) receptor antagonist indicated for the treatment of: Treatment-resistant depression (TRD) in adults, as monotherapy or in conjunction with an oral antidepressant. ( 1 ) Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant. ( 1 ) Limitations of Use: The effectiveness of SPRAVATO in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO. ( 1 ) SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO as an anesthetic agent have not been established. ( 1 ) Limitations of Use The effectiveness of SPRAVATO in…
Phase breakdown
Conditions being studied
Recruiting trials involving Esketamine
- A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
- Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
- Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery
- Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients
- Esketamine in Microelectrode Recording-guided Subthalamic Deep-Brain Stimulation for Parkinson's Disease
- Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression
- Metabolic Profiling of Esketamine Treatment in Depressive Disorder
- Personalized DBS Targeting for Treating Depression
- University of Iowa Interventional Psychiatry Service Patient Registry
Common questions
Is Esketamine FDA-approved?
Yes, marketed as Spravato. Its FDA label carries a boxed warning.
How many recruiting trials involve Esketamine?
9 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.