21 completed, 2 unknown, 1 active not recruiting, 1 withdrawn. 25 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 25 | Completed 21, Unknown 2, Active not recruiting 1, Withdrawn 1 |
| Phase 2 | 2 | Active not recruiting 1, Completed 1 |
Follow Esketamine: new trials by email Literature Review of Esketamine trials Research Report on Esketamine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Combining Esketamine and Prolonged Exposure Treatment for PTSD (Post Traumatic Stress Disorder) Esketamine (Intranasal Spray), Massed Prolonged Exposure (PE) - Post Traumatic Stress Disorder PTSD | Phase 1 / Phase 2 | Completed | The University of Texas Health Science Center at San Antonio | 4 | 2025-06-09 | 2026-01-28 |
| Effects of Esketamine Versus Magnesium Sulfate on Emotional State and Postoperative Pain in Patients Undergoing Nasal Endoscopic Surgery Esketamine, Magnesium sulfate, Saline - Chronic Rhinosinusitis, Enhanced Recovery After Surgery | Phase 1 / Phase 2 | Active not recruiting | The Second People's Hospital of Huai'an | 144 | 2025-03-01 | 2025-04-10 |
| KF2024#1-trial: Esketamine Interaction Study Esketamine Nasal Spray, Esketamine 28 mg, Cobicistat 150 MG - Drug Interactions, Food-drug Interaction | Phase 1 | Completed | Helsinki University Central Hospital | 12 | 2024-12-09 | 2026-03-05 |
| KetaMoHydBup: Pharmacokinetic Interaction of S-ketamine, Morphine, Hydromorphone and Buprenorphine S-ketamine - The Effect of S-ketamine on Pharmacokinetics of Morphine, Hydromorphone, and Buprenorphine | Phase 1 | Unknown | Elina Brinck | 12 | 2023-01-01 | 2022-10-07 |
| A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression Esketamine, Cognitive Behavioral Therapy (CBT), Antidepressant - Depression | Phase 1 | Withdrawn | Janssen Research & Development, LLC | 2022-09-01 | 2025-04-27 | |
| Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI 56mg esketamine (2x Spravato® 28 mg nasal spray), 0.9% saline solution nasal spray - Ketamine Treatment | Phase 1 | Completed | Rupert Lanzenberger | 33 | 2022-06-01 | 2024-04-15 |
| Imaging Neural Correlates of Ketamine Using PET/MR Ketamine Hydrochloride, Esketamine, Placebo - Major Depressive Disorder | Phase 1 | Unknown | Medical University of Vienna | 65 | 2020-10-05 | 2024-03-04 |
| A Study to Assess the Effect of Ticlopidine on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants Esketamine, Ticlopidine - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 16 | 2017-09-26 | 2025-04-27 |
| 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 Placebo (Intranasal), Esketamine, Alcohol - Depressive Disorder, Major | Phase 1 | Completed | Janssen Research & Development, LLC | 27 | 2016-10-07 | 2025-04-27 |
| Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly Japanese, and Healthy Younger Adult Japanese Subjects Esketamine - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 37 | 2016-08-09 | 2025-02-03 |
| Crossover Study to Evaluate the Abuse Potential of Intranasal Esketamine Compared to Racemic Intravenous Ketamine in Nondependent, Recreational Drug Users Intravenous placebo, Intranasal placebo, Intravenous racemic ketamine - Drug Abuse | Phase 1 | Completed | Janssen Research & Development, LLC | 55 | 2016-03-25 | 2025-04-27 |
| A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants Esketamine 50 mg, Esketamine 20 mg - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 8 | 2016-03-01 | 2025-02-03 |
| 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 Esketamine, Rifampin - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 66 | 2016-02-26 | 2025-04-27 |
| A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine Esketamine - Renal Impairment, Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 32 | 2015-12-04 | 2025-04-27 |
| A Study to Assess the Effects of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine Esketamine - Hepatic Impairment, Normal Hepatic Function | Phase 1 | Completed | Janssen Research & Development, LLC | 24 | 2015-11-30 | 2025-02-03 |
| Pharmacokinetic Study of Intranasal Esketamine and Its Effects on the Pharmacokinetics of Orally-Administered Midazolam and Bupropion in Healthy Participants Midazolam, Esketamine, Bupropion - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 71 | 2015-10-01 | 2025-02-03 |
| 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 Esketamine, Clarithromycin - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 18 | 2015-01-01 | 2015-09-28 |
| Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult Participants Esketamine - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 16 | 2014-12-01 | 2017-03-03 |
| Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants Esketamine, Mirtazapine, Placebo (Matched to Esketamine) - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 26 | 2014-09-01 | 2014-12-30 |
| A Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects Esketamine, Placebo - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 24 | 2014-06-01 | 2014-10-16 |
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Depressive Disorder, Major (2) · Combat Disorders (1) · Depression (1) · Renal Insufficiency (1) · Rhinitis, Allergic (1) · Substance-Related Disorders (1)
Janssen Research & Development, LLC (19) · Elina Brinck (1) · Helsinki University Central Hospital (1) · Medical University of Vienna (1) · Rupert Lanzenberger (1) · The Second People's Hospital of Huai'an (1) · The University of Texas Health Science Center at San Antonio (1)
United States (9) · Belgium (7) · Netherlands (3) · Austria (2) · China (1) · Finland (1) · Germany (1)
Casey Straud, PsyD (1) · Janne T Backman, MD, PhD (1) · Tuomas Lilius, MD, PhD (1)
PMID 33128208, PMID 29392371, PMID 35212235, PMID 37402024, PMID 41693798
2014 (5), 2015 (1), 2016 (1), 2017 (1)