Esketamine clinical trials: pipeline by phase and status

All 84 trials

Most advanced phase first, and within each phase the most recent start date first.

Phase 4 12 trials

• Esketamine Versus Crisis Response Planning Versus Enhanced Treatment as Usual for Suicide Prevention: A Pragmatic Randomized Trial in a Brazilian Municipality (SAVE) (opens in new tab)

  Recruiting Phase 4 478 participants University of Sao Paulo Started 2026

  Suicide Prevention, Ketamine, Crisis Response Plan

• Esketamine With or Without Integration Therapy for Treatment-Resistant Depression (opens in new tab)

  Recruiting Phase 4 20 participants University of Puerto Rico Started 2026

  Treatment-resistant Depression (TRD)

• A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression (opens in new tab)

  Completed Phase 4 47 participants Janssen Korea, Ltd., Korea Started 2025

  Depressive Disorder, Treatment-Resistant

• Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression (opens in new tab)

  Recruiting Phase 4 162 participants The George Institute Started 2024

  Treatment Resistant Depression

• Positioning of Esketamine Treatment in the Real-world Management of Depression (opens in new tab)

  Recruiting Phase 4 162 participants Royal North Shore Hospital Started 2023

  Major Depressive Disorder

• VA Aripiprazole vs Esketamine for Treatment Resistant Depression (opens in new tab)

  Withdrawn Phase 4 0 participants VA Office of Research and Development Started 2023

  Depressive Disorder, Major

• Effect of Low-dose Esketamine on Maternal Depression at 3 Years After Childbirth (opens in new tab)

  Active, not recruiting Phase 4 364 participants Peking University First Hospital Started 2023

  Prenatal Depression, Ketamine, Postpartum Depression

• Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression (opens in new tab)

  Recruiting Phase 4 100 participants Massachusetts General Hospital Started 2022

  Major Depressive Disorder

• Safety and Efficacy Evaluation of S (+) - Ketamine in Children (opens in new tab)

  Unknown status Phase 4 3,000 participants Chinese PLA General Hospital Started 2022

  S-ketamine, Esketamine, Acute Pain, Postoperative Pain

• Effects of Esketamine on Postpartum Depression (opens in new tab)

  Unknown status Phase 4 500 participants Qinghai University Started 2022

  Postpartum Depression

• A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment (opens in new tab)

  Completed Phase 4 183 participants Janssen-Cilag Ltd. Started 2021

  Depressive Disorder, Major

• A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression (opens in new tab)

  Completed Phase 4 477 participants Janssen Research & Development, LLC Started 2020

  Depressive Disorder, Treatment-Resistant

Phase 3 19 trials

• A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression (opens in new tab)

  Recruiting Phase 3 348 participants Janssen Research & Development, LLC Started 2026

  Depressive Disorder, Treatment-Resistant

• A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder (opens in new tab)

  Recruiting Phase 3 258 participants Janssen Research & Development, LLC Started 2026

  Depressive Disorder, Major

• Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients (opens in new tab)

  Not yet recruiting Phase 3 220 participants Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Started 2025

  Depressive Disorder

• Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure (opens in new tab)

  Recruiting Phase 3 1,254 participants Dr. Inge Winter Started 2025

  Schizophrenia and Related Disorders, Major Depressive Disorder, Bipolar Depression

• PCORI Comparative Effectiveness Study-Esketamine (Spravato) vs. Ketamine-Equivalence Study (opens in new tab)

  Recruiting Phase 3 400 participants Yale University Started 2025

  Depression

• The Effect of a Six Week Intensified Pharmacological Treatment for Major Depressive Disorder Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. (opens in new tab)

  Recruiting Phase 3 418 participants Dr. Inge Winter Started 2024

  Major Depressive Disorder, Treatment Resistant Depression

• ECT vs. Esketamine (opens in new tab)

  Withdrawn Phase 3 0 participants Medical University Innsbruck Started 2021

  Treatment Resistant Depression, Major Depressive Disorder

• An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives (opens in new tab)

  Completed Phase 3 41 participants Janssen-Cilag, S.A. Started 2020

  Depression

• 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 (opens in new tab)

  Completed Phase 3 676 participants Janssen-Cilag International NV Started 2020

  Depressive Disorder, Major

• 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 (opens in new tab)

  Withdrawn Phase 3 0 participants Janssen-Cilag International NV Started 2019

  Depressive Disorder, Treatment-Resistant

• 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 (opens in new tab)

  Completed Phase 3 252 participants Janssen Research & Development, LLC Started 2018

  Depressive Disorder, Treatment-Resistant

• 54135419SUI3002: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide (opens in new tab)

  Completed Phase 3 230 participants Janssen Research & Development, LLC Started 2017

  Depressive Disorder, Major

• 54135419SUI3001: A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Participants Assessed to be at Imminent Risk for Suicide (opens in new tab)

  Completed Phase 3 226 participants Janssen Research & Development, LLC Started 2017

  Depressive Disorder, Major

• A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression (opens in new tab)

  Completed Phase 3 1,148 participants Janssen Research & Development, LLC Started 2016

  Depressive Disorder, Treatment-Resistant

• A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression (opens in new tab)

  Completed Phase 3 719 participants Janssen Research & Development, LLC Started 2015

  Depressive Disorder, Treatment-Resistant

• A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression (opens in new tab)

  Completed Phase 3 802 participants Janssen Research & Development, LLC Started 2015

  Treatment-resistant Depression

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

  Completed Phase 3 139 participants Janssen Research & Development, LLC Started 2015

  Depressive Disorder, Treatment-Resistant

• 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 (opens in new tab)

  Completed Phase 3 346 participants Janssen Research & Development, LLC Started 2015

  Treatment-resistant Depression

• 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 (opens in new tab)

  Completed Phase 3 236 participants Janssen Research & Development, LLC Started 2015

  Treatment-resistant Depression

Phase 2 14 trials

• Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay (opens in new tab)

  Not yet recruiting Phase 2 106 participants University of Sao Paulo Started 2027

  Suicidal Ideation, Suicidal Behavior

• Ayahuasca, Esketamine and PTSD (opens in new tab)

  Recruiting Phase 2 10 participants University of Sao Paulo Started 2025

  Posttraumatic Stress Disorder (PTSD)

• A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder (opens in new tab)

  Completed Phase 2 99 participants Clexio Biosciences Ltd. Started 2024

  Adjunctive Treatment of Major Depressive Disorder (MDD)

• Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder - 3 Month Extension Study (opens in new tab)

  Withdrawn Phase 2 0 participants Zylorion Health Started 2023

  Treatment Resistant Major Depressive Disorder

• Ayahuasca and Esketamine for Major Depression (opens in new tab)

  Completed Phase 2 22 participants University of Sao Paulo Started 2022

  Major Depression Severe

• Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression (opens in new tab)

  Terminated Phase 2 6 participants Zylorion Health Started 2022

  Treatment Resistant Major Depressive Disorder

• A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study (opens in new tab)

  Completed Phase 2 146 participants Clexio Biosciences Ltd. Started 2019

  Adjunctive Treatment of Major Depressive Disorder

• Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Bipolar Depression (opens in new tab)

  Completed Phase 2 88 participants Celon Pharma SA Started 2019

  Bipolar Depression

• Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression (opens in new tab)

  Completed Phase 2 88 participants Celon Pharma SA Started 2019

  Major Depressive Disorder

• Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide (opens in new tab)

  Completed Phase 2 147 participants Janssen Research & Development, LLC Started 2017

  Depressive Disorder, Major

• A Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Participants With Treatment Resistant Depression (opens in new tab)

  Completed Phase 2 202 participants Janssen Pharmaceutical K.K. Started 2016

  Depression

• 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 (opens in new tab)

  Completed Phase 2 68 participants Janssen Research & Development, LLC Started 2014

  Major Depressive Disorder

• A Study to Evaluate the Safety and Efficacy of Intranasal Esketamine in Treatment-resistant Depression (opens in new tab)

  Completed Phase 2 108 participants Janssen Research & Development, LLC Started 2014

  Treatment Resistant Depressive Disorder

• A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression (opens in new tab)

  Completed Phase 2 30 participants Janssen Research & Development, LLC Started 2012

  Major Depressive Disorder

Phase 1/2 1 trial

• Combining Esketamine and Prolonged Exposure Treatment for PTSD (Post Traumatic Stress Disorder) (opens in new tab)

  Completed Phase 1/2 4 participants The University of Texas Health Science Center at San Antonio Started 2025

  Post Traumatic Stress Disorder PTSD

Phase 1 3 trials

• 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 (opens in new tab)

  Withdrawn Phase 1 0 participants Janssen Research & Development, LLC Started 2022

  Depression

• Imaging Neural Correlates of Ketamine Using PET/MR (opens in new tab)

  Unknown status Phase 1 65 participants Medical University of Vienna Started 2020

  Major Depressive Disorder

• 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 (opens in new tab)

  Completed Phase 1 27 participants Janssen Research & Development, LLC Started 2016

  Depressive Disorder, Major

Early phase 1 3 trials

• Subanesthetic Esketamine in Modified ECT for Severe Depression in Adolescents: Clinical and Mechanistic Study (opens in new tab)

  Recruiting Early Phase 1 220 participants Min Su Started 2025

  Esketamine, ECT, Depression, Adolescent

• Personalized DBS Targeting for Treating Depression (opens in new tab)

  Recruiting Early Phase 1 5 participants Second Affiliated Hospital, Zhejiang University, School of Medicine Started 2025

  Treatment-resistant Depression (TRD)

• The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy (opens in new tab)

  Unknown status Early Phase 1 396 participants First Affiliated Hospital of Chongqing Medical University Started 2021

  Esketamine, ECT, Depression

Not applicable 21 trials

• Psychotherapy Combined With Intranasal Esketamine for the Treatment of Suicidal Ideation (opens in new tab)

  Enrolling by invitation 56 participants University of California, San Diego Started 2026

  Suicidal Ideation

• Ayahuasca, Esketamine and Premenstrual Symptoms (opens in new tab)

  Recruiting 20 participants University of Sao Paulo Started 2025

  Healthy Women Volunteers

• Ayahuasca, Esketamine and Body Image Perception (opens in new tab)

  Recruiting 20 participants University of Sao Paulo Started 2025

  Healthy Women Volunteers

• Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression (opens in new tab)

  Recruiting 30 participants Hospital Universitari Vall d'Hebron Research Institute Started 2025

  Depression - Major Depressive Disorder, Depression Disorder, Depression Chronic, Treatment-Resistant Major Depressive Disorder

• Esketamine for Prevention of Depression After Cytoreductive Surgery in Ovarian Cancer (opens in new tab)

  Completed 568 participants Zhejiang Cancer Hospital Started 2024

  Ovarian Cancer, Cytoreductive Surgery, Depressive Symptom

• Role Of Non-Specific Effects in The Treatment of Depression With Esketamine (opens in new tab)

  Terminated 1 participants Yale University Started 2024

  Depressive Episode

• Using Virtual Reality to Control the Audio-visual Inputs During Ketamine/Esketamine Treatment (opens in new tab)

  Completed 7 participants Yale University Started 2024

  Depression

• (GluEsk) Glutamate and Esketamine (opens in new tab)

  Completed 16 participants University of Oxford Started 2024

  Depression

• Behavioural Activation Therapy and Esketamine for Resistant Depression (opens in new tab)

  Terminated 6 participants The Royal's Institute of Mental Health Research Started 2024

  Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major, Bipolar Disorder

• Esketamine vs ECT for Acute Suicidality (opens in new tab)

  Completed 340 participants Capital Medical University Started 2024

  Mood Disorders, Suicidal Ideation, Depressive Episode

• Phenomenological Explorations of the Esketamine-Induced Transient Dissociative State (opens in new tab)

  Completed 15 participants Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer Started 2024

  Depressive Disorder

• Effect of Esketamine on Depressive Symptoms of Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy (opens in new tab)

  Unknown status 400 participants The Second Hospital of Anhui Medical University Started 2024

  Depressive Symptoms

• Testing the Effectiveness of Cognitive Training Among Depressed Patients Receiving Esketamine Treatment (opens in new tab)

  Suspended 40 participants University of Pittsburgh Started 2023

  Depression

• Esketamine Adjuvant Therapy for Patients With Chronic Visceral Pain Comorbid Major Depressive Disorder (opens in new tab)

  Unknown status 80 participants Peking University Started 2021

  Chronic Visceral Pain, Major Depressive Disorder

• Esketamine on Postpartum Depression in Cesarean Section Women (opens in new tab)

  Completed 336 participants Ailin Luo Started 2021

  Esketamine, Postpartum Depression

• Add-on Therapy With Edupression.Com® on Therapy Resistant Depressive Patients Treated With Nasal Esketamine Spray (opens in new tab)

  Unknown status 70 participants Lukas Pezawas Started 2021

  Major Depressive Disorder, Therapy Resistant Depression

• Cognitive Behavioral Therapy Following Esketamine for Major Depression and Suicidal Ideation for Relapse Prevention (opens in new tab)

  Completed 93 participants Yale University Started 2021

  Depression and Suicide

• The Efficacy and Safety of S-ketamine in Elective Cesarean Section (opens in new tab)

  Unknown status 402 participants Beijing Obstetrics and Gynecology Hospital Started 2020

  Anesthesia, Analgesia, Depression, Cesarean Section

• The Effect of S-ketamine for Patients Undergoing Electroconvulsive Therapy (ECT) (opens in new tab)

  Unknown status 150 participants Yan Qiu Started 2020

  Depression, Bipolar, Depression, Unipolar, Major Depressive Disorder, Manic-Depressive - Now Depressed

• Low-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression (opens in new tab)

  Completed 364 participants Peking University First Hospital Started 2020

  Prenatal Depression, Ketamine, Postpartum Depression

• Low-dose S-ketamine in Women With Prenatal Depression (opens in new tab)

  Completed 364 participants Peking University First Hospital Started 2020

  Prenatal Depression, Ketamine, Postpartum Depression

Unspecified 11 trials

• Retrospective Analyses of the Greenbrook Database Evaluating Mental Health Treatments (opens in new tab)

  Recruiting 12,000 participants Neuronetics Started 2025

  Depression, OCD, Anxiety Depression

• Link Between Reduction of Suicide Ideation by Esketamine in Add-On and Initial Levels of Psychological Pain and Anhedonia (opens in new tab)

  Active, not recruiting 456 participants University Hospital, Montpellier Started 2024

  Depression - Major Depressive Disorder, Depression Disorder, Suicide

• The OBSERVE Protocol (opens in new tab)

  Recruiting 450 participants Yale University Started 2024

  Major Depression Disorder

• Brain Network Dynamics of Depression During Esketamine Treatment (opens in new tab)

  Completed 8 participants University of North Carolina, Chapel Hill Started 2023

  Depressive Disorder, Major

• Metabolic Profiling of Esketamine Treatment in Depressive Disorder (opens in new tab)

  Recruiting 100 participants University of Zagreb Started 2023

  Major Depressive Disorder

• IV Ketamine vs. IN Esketamine for MDD TRD (opens in new tab)

  Unknown status 80 participants Gustavo Vazquez Started 2023

  Treatment Resistant Depression

• Esketamine Nasal Spray in Real-World Settings in Treatment-Resistant Depression (opens in new tab)

  Recruiting 100 participants Riccardo Guglielmo Started 2022

  Depression and Quality of Life, Treatment Resistant Depression (TRD), Anhedonia, Apathy

• Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective MAOI (opens in new tab)

  Completed 13 participants University Hospital, Strasbourg, France Started 2022

  Depression Anxiety Disorder

• University of Iowa Interventional Psychiatry Service Patient Registry (opens in new tab)

  Recruiting 1,000 participants Mark Niciu Started 2020

  Treatment Resistant Depression, Major Depressive Episode, Major Depression, Major Depressive Disorder

• Intranasal Esketamine to Maintain the Antidepressant Response to IV Racemic Ketamine (opens in new tab)

  Completed 10 participants Psych Atlanta Started 2018

  Treatment Resistant Depression

• Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD) (opens in new tab)

  Approved For Marketing Janssen Research & Development, LLC

  Depressive Disorder, Treatment-Resistant