Esketamine

Generic Name: Esketamine

Brand Names: Spravato

Drug Type: Small Molecule

Chemical Formula: C_₁₃H_₁₆ClNO

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.
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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

Clinical Trials

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

Phase 3

Completed

Conditions: Treatment-resistant Depression

Interventions: Drug: Placebo
Drug: Esketamine
Drug: Duloxetine (Oral Antidepressant)
Drug: Escitalopram (Oral antidepressant)
Drug: Sertraline (Oral Antidepressant)
Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant)

First Posted Date: 2015-04-15

Last Posted Date: 2020-05-04

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 346

Registration Number: NCT02417064

Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Esketamine

First Posted Date: 2015-01-26

Last Posted Date: 2017-03-03

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 16

Registration Number: NCT02345148

A Study to Evaluate the Absolute Bioavailability of Intranasal and Oral Esketamine and the Effects of Clarithromycin on the Pharmacokinetics of Intranasal Esketamine in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Esketamine
Drug: Clarithromycin

First Posted Date: 2015-01-21

Last Posted Date: 2015-09-28

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 18

Registration Number: NCT02343289

Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Esketamine
Drug: Mirtazapine
Drug: Placebo (Matched to Esketamine)
Drug: Placebo (Matched to Mirtazapine)

First Posted Date: 2014-08-28

Last Posted Date: 2014-12-30

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 26

Registration Number: NCT02228239

Study to Assess the Effects of Allergic Rhinitis and Co-administration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine

Phase 1

Completed

Conditions: Allergic Rhinitis

Interventions: Drug: Esketamine
Drug: Oxymetazoline
Drug: Mometasone

First Posted Date: 2014-06-03

Last Posted Date: 2015-12-24

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 47

Registration Number: NCT02154334

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

Phase 2

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Placebo
Drug: Esketamine

First Posted Date: 2014-05-07

Last Posted Date: 2024-07-03

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 68

Registration Number: NCT02133001

A Pharmacokinetic, Safety and Tolerability Study of Esketamine in Healthy Elderly and Adult Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Esketamine
Drug: Placebo

First Posted Date: 2014-05-02

Last Posted Date: 2014-07-25

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 34

Registration Number: NCT02129088

A Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Esketamine
Drug: Placebo

First Posted Date: 2014-03-21

Last Posted Date: 2014-10-16

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 24

Registration Number: NCT02094378

A Study to Evaluate the Pharmacokinetics of Intranasal Esketamine Administered With and Without a Nasal Guide on the Intranasal Device

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Esketamine

First Posted Date: 2014-02-12

Last Posted Date: 2014-03-13

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 14

Registration Number: NCT02060929

A Study to Assess the Pharmacokinetics of Intranasally Administered Esketamine in Healthy Japanese and Caucasian Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Esketamine

First Posted Date: 2013-11-08

Last Posted Date: 2014-01-28

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 29

Registration Number: NCT01980303

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