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 Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Participants With Major Depressive Disorder

Phase 1

Completed

Conditions: Depressive Disorder, Major

Interventions: Drug: Placebo (Intranasal)
Drug: Esketamine
Other: Alcohol
Drug: Placebo (Oral)

First Posted Date: 2016-09-29

Last Posted Date: 2019-04-24

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 27

Registration Number: NCT02919579

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Esketamine

First Posted Date: 2016-08-05

Last Posted Date: 2017-03-14

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 37

Registration Number: NCT02857777

Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Esketamine
Drug: Rifampin

First Posted Date: 2016-07-27

Last Posted Date: 2019-03-26

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 66

Registration Number: NCT02846519

The Neural Mechanisms of Anesthesia and Human Consciousness (Part 6)

Phase 4

Completed

Conditions: Unconsciousness
Anesthesia

Interventions: Drug: Placebo
Drug: Dexmedetomidine
Drug: Propofol
Drug: S-ketamine
Drug: Sevoflurane

First Posted Date: 2015-12-08

Last Posted Date: 2017-03-27

Lead Sponsor: University of Turku

Target Recruit Count: 160

Registration Number: NCT02624401

Locations: 🇫🇮
Turku PET Centre, Turku, Finland

A Study to Assess the Effects of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine

Phase 1

Completed

Conditions: Hepatic Impairment
Normal Hepatic Function

Interventions: Drug: Esketamine

First Posted Date: 2015-11-20

Last Posted Date: 2017-05-15

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 24

Registration Number: NCT02611505

A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine

Phase 1

Completed

Conditions: Healthy
Renal Impairment

Interventions: Drug: Esketamine

First Posted Date: 2015-11-17

Last Posted Date: 2019-03-29

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 32

Registration Number: NCT02606084

Pharmacokinetic Study of Intranasal Esketamine and Its Effects on the Pharmacokinetics of Orally-Administered Midazolam and Bupropion in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Midazolam
Drug: Esketamine
Drug: Bupropion

First Posted Date: 2015-10-05

Last Posted Date: 2017-02-17

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 71

Registration Number: NCT02568176

A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression

Phase 3

Completed

Conditions: Depressive Disorder, Treatment-Resistant

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: 2015-07-10

Last Posted Date: 2020-06-02

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 719

Registration Number: NCT02493868

A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression

Phase 3

Completed

Conditions: Depressive Disorder, Treatment-Resistant

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

First Posted Date: 2015-04-21

Last Posted Date: 2021-09-29

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 139

Registration Number: NCT02422186

A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible 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: 2015-04-16

Last Posted Date: 2020-06-02

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 236

Registration Number: NCT02418585

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