Esketamine 84 mg

DRUG7 trials

Conditions

Depressive Disorder, MajorDepressive Disorder, Treatment-ResistantDrug AbuseTreatment Resistant Depressive Disorder

Phase 1

Crossover Study to Evaluate the Abuse Potential of Intranasal Esketamine Compared to Racemic Intravenous Ketamine in Nondependent, Recreational Drug Users

CompletedNCT02682225

Janssen Research & Development, LLCDrug Abuse

Start: 2016-03-25End: 2017-01-09Updated: 2025-04-27

Phase 2

A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression

CompletedNCT01998958

Janssen Research & Development, LLCTreatment Resistant Depressive Disorder

Start: 2014-01-27End: 2015-09-25Updated: 2025-04-29

Phase 3

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

CompletedNCT03434041

Janssen Research & Development, LLCDepressive Disorder, Treatment-Resistant

Start: 2018-05-25End: 2021-04-13Updated: 2025-04-29

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

WithdrawnNCT03852160

Janssen-Cilag International NVDepressive Disorder, Treatment-Resistant

Start: 2019-12-01End: 2021-07-25Updated: 2025-04-27

A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder

CompletedNCT04338321

Janssen-Cilag International NVDepressive Disorder, Major

Start: 2020-08-21End: 2022-07-15Updated: 2025-04-29

Phase 4

A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

CompletedNCT04599855

Janssen Research & Development, LLCDepressive Disorder, Treatment-Resistant

Start: 2020-11-04End: 2024-01-31Updated: 2025-04-25

A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression

RecruitingNCT07053345

Janssen Korea, Ltd., KoreaDepressive Disorder, Treatment-Resistant

Start: 2025-06-09End: 2027-06-25Target: 47Updated: 2026-03-13

European Neuropsychopharmacology2026-02-27

Improvements in health-related quality of life with esketamine nasal spray versus quetiapine extended release.

2025-10-14

Assessment of patient-reported depression severity in subpopulation of ESCAPE-TRD study: esketamine nasal spray versus quetiapine extended release for treatment-resistant depression.

2025-08-01

Esketamine Monotherapy in Adults With Treatment-Resistant Depression

JAMA Psychiatry2025-07-0212 citations

Safety and efficacy with esketamine in treatment-resistant depression: long-term extension study

The International Journal of Neuropsychopharmacology2025-05-0412 citations

Improvements in functioning and workplace productivity with esketamine nasal spray versus quetiapine extended release in patients with treatment resistant depression: Findings from a 32-week randomised, open-label, rater-blinded phase IIIb study

European Neuropsychopharmacology2025-02-087 citations

Esketamine nasal spray versus quetiapine XR in adults with treatment-resistant depression: a secondary analysis of the ESCAPE-TRD randomized clinical trial

CNS Spectrums2025-01-014 citations

Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission: results from the ICEBERG study

Frontiers in Psychiatry2024-10-073 citations

Adverse Event Duration with Esketamine Versus Quetiapine XR in Adults With Treatment-Resistant Depression: A Subgroup Analysis of ESCAPE-TRD

CNS Spectrums2024-10-01

Safety and tolerability of esketamine nasal spray versus quetiapine extended release in patients with treatment resistant depression.

2024-07-0112 citations

Esketamine nasal spray shows greater improvement in health-related quality of life over 32 weeks versus quetiapine extended release in patients with treatment resistant depression

European Psychiatry2024-04-01

Weight changes in esketamine nasal spray and quetiapine extended-release treated patients with treatment resistant depression: Results from ESCAPE-TRD study

European Psychiatry2024-04-01

Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression: results from the ICEBERG study

Frontiers in Psychiatry2023-10-316 citations

ICEBERG study: an indirect adjusted comparison estimating the long-term benefit of esketamine nasal spray when compared with routine treatment of treatment resistant depression in general psychiatry

Frontiers in Psychiatry2023-10-314 citations

Esketamine Nasal Spray versus Quetiapine for Treatment-Resistant Depression

New England Journal of Medicine2023-10-04155 citations

Esketamine Nasal Spray Improves Rate and Time to Remission Versus Quetiapine Extended Release in Subgroups of Patients With Treatment Resistant Depression and Two or Three Plus Prior Treatment Failures: Results From ESCAPE-TRD, a Randomised Phase IIIb Trial

BJPsych Open2023-07-012 citations

Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Plus a Newly Initiated Oral Antidepressant in Adult Patients with Treatment-Resistant Depression: A Randomized, Double-Blind, Multicenter, Active-Controlled Study Conducted in China and USA.

2023-03-3124 citations

Esketamine nasal spray shows higher remission and response rates over 32 weeks of treatment compared with quetiapine extended-release in patients with treatment resistant depression: Results from ESCAPE-TRD, a randomised, phase IIIb clinical trial

2023-03-01

Efficacy and safety of fixed doses of intranasal Esketamine as an add-on therapy to Oral antidepressants in Japanese patients with treatment-resistant depression: a phase 2b randomized clinical study

BMC Psychiatry2021-10-2553 citations

Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression.

2020-10-3134 citations

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