The near end of the pipeline

Phase 3 programs

Phase 3 tests whether a treatment works in a large population, and it is the last step before a company can file for approval. What happens here decides whether any of these substances becomes a prescription medicine.

Trials listed

Recruiting

In Phase 3

With results posted

Trial	Status	Phase	Substance	Sites
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress DisorderNCT07570654 · COMPASS Pathways	Recruiting	Phase 2 / Phase 3	psilocybin	1
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive DisorderNCT06793397 · Cybin IRL Limited	Recruiting	Phase 3	psilocybin	68
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant DepressionNCT07226232 · VA Office of Research and Development	Recruiting	Phase 3	psilocybin	5
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive DisorderNCT06247839 · Sharmin Ghaznavi	Recruiting	Phase 3	psilocybin	1
InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpressionNCT06781697 · Sunnybrook Health Sciences Centre	Recruiting	Phase 3	ketamine	1
A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)NCT07592689 · Definium Therapeutics US, Inc.	Recruiting	Phase 3	lsd	30
PCORI Comparative Effectiveness Study-Esketamine (Spravato) vs. Ketamine-Equivalence StudyNCT06713616 · Yale University	Recruiting	Phase 3	ketamine	8
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive DisorderNCT07227454 · Janssen Research & Development, LLC	Recruiting	Phase 3	ketamine	35
A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant DepressionNCT07716098 · Janssen Research & Development, LLC	Recruiting	Phase 3	ketamine	4
Ketamine Treatment of Youth Suicide AttemptersNCT04763343 · Tatiana Falcone, MD	Recruiting	Phase 3	ketamine	1
Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Major Depressive DisorderNCT07703722 · Khyber Medical University Peshawar	Recruiting	Phase 3	psilocybin	3
Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)NCT07063862 · Bruyère Health Research Institute.	Recruiting	Phase 3	psilocybin	7
Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive SymptomsNCT07638553 · Centre Hospitalier Universitaire de Nīmes	Recruiting	Phase 3	psilocybin	8
MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use DisorderNCT07118839 · VA Office of Research and Development	Recruiting	Phase 2 / Phase 3	mdma	2
Understanding and Treating Suicidal Ideation With KetamineNCT06891300 · The Royal's Institute of Mental Health Research	Recruiting	Phase 2 / Phase 3	ketamine	1
Ketamine Augmentation of ECT in Treatment-Resistant DepressionNCT07088380 · Università Vita-Salute San Raffaele	Recruiting	Phase 3	ketamine	1
MDMA-assisted Massed Prolonged Exposure for PTSDNCT06117306 · Healing Breakthrough	Recruiting	Phase 3	mdma	1
Nebulized Ketamine for the Treatment of Major Depressive DisorderNCT06752759 · Theresa Jacob, PhD, MPH	Recruiting	Phase 3	ketamine	1
Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment FailureNCT05603104 · Dr. Inge Winter	Recruiting	Phase 3	ketamine	1
Psilocybin Therapy in Advanced CancerNCT05398484 · NYU Langone Health	Recruiting	Phase 2 / Phase 3	psilocybin	2
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.NCT05973851 · Dr. Inge Winter	Recruiting	Phase 3	ketamine	12
Early Effects of Ketamine vs Placebo With Venlafaxine in Severe Depression PatientsNCT06508710 · Assistance Publique - Hôpitaux de Paris	Recruiting	Phase 3	ketamine	4
Ketamine & Crisis Response Plan for Suicidal Ideation in the EDNCT05696691 · The University of Texas Health Science Center at San Antonio	Recruiting	Phase 2 / Phase 3	ketamine	1
Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral InjuryNCT06394284 · Herzog Hospital	Recruiting	Phase 3	mdma	1
Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility TrialNCT05233566 · Washington University School of Medicine	Completed	Phase 3	ketamine	1
"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder"NCT06564818 · Cybin IRL Limited	Active, not recruiting	Phase 3	psilocybin	45
Efficacy, Safety, and Tolerability of COMP360 in Participants With TRDNCT05624268 · COMPASS Pathways	Completed	Phase 3	psilocybin	40
Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRDNCT05711940 · COMPASS Pathways	Active, not recruiting	Phase 3	psilocybin	116
A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)NCT06809595 · Definium Therapeutics US, Inc.	Active, not recruiting	Phase 3	lsd	36
A Phase 3 Trial of DT120 for Major Depressive Disorder (Emerge)NCT06941844 · Definium Therapeutics US, Inc.	Active, not recruiting	Phase 3	lsd	22
Psilocybin for Major Depressive Disorder (MDD)NCT06308653 · Usona Institute	Active, not recruiting	Phase 3	psilocybin	29
A Phase 3 Trial of DT120 for Generalized Anxiety Disorder (Voyage)NCT06741228 · Definium Therapeutics US, Inc.	Active, not recruiting	Phase 3	lsd	34
Opioid-Free Pain Control Regimen Following Robotic Radical ProstatectomyNCT05597878 · Wake Forest University Health Sciences	Terminated	Phase 2 / Phase 3	ketamine	1
Opiate Suicide Study in Patients With Major DepressionNCT04116528 · Stanford University	Completed	Phase 3	ketamine	1
Predictors of Intravenous Ketamine Response in TRDNCT05625555 · Abraham Nunes	Active, not recruiting	Phase 3	ketamine	1
Psilocybin-Assisted Therapy in Treatment-Resistant DepressionNCT06303739 · University of North Carolina, Chapel Hill	Active, not recruiting	Phase 3	psilocybin	1
Epigenetics and MDMA-Assisted Psychotherapy for PTSDNCT06189027 · University of Southern California	Completed	Phase 3	mdma	1
Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II DisorderNCT06943573 · Lakshmi N Yatham	Not yet recruiting	Phase 3	psilocybin	3
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive DiseaseNCT02783430 · University Hospital, Lille	Completed	Phase 2 / Phase 3	ketamine	9
MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSDNCT05979844 · Dr. Leslie Morland	Completed	Phase 3	mdma	1
Effects of Ketamine in the Acute Phase of Suicidal IdeationNCT02299440 · Centre Hospitalier Universitaire de Nīmes	Completed	Phase 3	ketamine	9
Ketamine Versus Midazolam for Recurrence of Suicidality in AdolescentsNCT04592809 · University of Texas Southwestern Medical Center	Completed	Phase 3	ketamine	1
The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case SeriesNCT06048263 · Washington University School of Medicine	Withdrawn	Phase 2 / Phase 3	ketamine	1
Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly PatientsNCT07153406 · Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	Not yet recruiting	Phase 3	ketamine	9
Esketamine and Perioperative Depressive SymptomsNCT04425473 · Beijing Tiantan Hospital	Completed	Phase 2 / Phase 3	ketamine	1
A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)NCT03537014 · Resilient Pharmaceuticals	Completed	Phase 3	mdma	15
A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)NCT04077437 · Resilient Pharmaceuticals	Completed	Phase 3	mdma	14
A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSDNCT04714359 · Resilient Pharmaceuticals	Completed	Phase 3	mdma	15
Initiating Ketamine in Acutely Suicidal Patients in the Emergency DepartmentNCT04260607 · Naval Medical Center Camp Lejeune	Terminated	Phase 3	ketamine	1
Evaluation of the Efficacy and Safety of Subcutaneous Ketamine in the Treatment of Depressive Episode With Suicidal Ideation and/or Behavior in AdolescentsNCT06957704 · Federal University of São Paulo	Not yet recruiting	Phase 3	ketamine	—
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 DepressionNCT02417064 · Janssen Research & Development, LLC	Completed	Phase 3	ketamine	90
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 DepressionNCT02418585 · Janssen Research & Development, LLC	Completed	Phase 3	ketamine	48
A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant DepressionNCT02422186 · Janssen Research & Development, LLC	Completed	Phase 3	ketamine	69
A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant DepressionNCT02493868 · Janssen Research & Development, LLC	Completed	Phase 3	ketamine	155
A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant DepressionNCT02497287 · Janssen Research & Development, LLC	Completed	Phase 3	ketamine	109
A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant DepressionNCT02782104 · Janssen Research & Development, LLC	Completed	Phase 3	ketamine	173
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 SuicideNCT03039192 · Janssen Research & Development, LLC	Completed	Phase 3	ketamine	56
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 SuicideNCT03097133 · Janssen Research & Development, LLC	Completed	Phase 3	ketamine	61
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 DepressionNCT03434041 · Janssen Research & Development, LLC	Completed	Phase 3	ketamine	30
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 DisorderNCT04338321 · Janssen-Cilag International NV	Completed	Phase 3	ketamine	171
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 DepressionNCT03852160 · Janssen-Cilag International NV	Withdrawn	Phase 3	ketamine	—
Frontline Clinician Psilocybin StudyNCT05163496 · University of Washington	Completed	Phase 3	psilocybin	1
Ketamine As an Adjunctive Therapy for Major Depression (2)NCT04939649 · University of Dublin, Trinity College	Completed	Phase 3	ketamine	1
NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar DepressionNCT03396601 · NeuroRx, Inc.	Unknown status	Phase 3	ketamine	2
ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)NCT03113968 · Bo Hu	Completed	Phase 2 / Phase 3	ketamine	5
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment AlternativesNCT04476446 · Janssen-Cilag, S.A.	Completed	Phase 3	ketamine	8
Sodium Lactate and Brain Relaxation (LSD)NCT04488874 · Centre Hospitalier Universitaire de Besancon	Completed	Phase 3	lsd	1
Ketamine Versus Electroconvulsive Therapy in DepressionNCT03674671 · University of Ottawa	Suspended	Phase 3	ketamine	4
Ketamine for Severe Adolescent Depression: Intermediate-term Safety and EfficacyNCT03889756 · Yale University	Terminated	Phase 2 / Phase 3	ketamine	1
Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol AbuseNCT03539887 · The University of Texas Health Science Center, Houston	Completed	Phase 3	ketamine	1
Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal IdeationNCT05468840 · University of Ottawa	Unknown status	Phase 3	ketamine	1
Ketamine to Prevent PPD After CesareanNCT04227704 · Washington University School of Medicine	Completed	Phase 3	ketamine	1
ECT vs. EsketamineNCT04924257 · Medical University Innsbruck	Withdrawn	Phase 3	ketamine	1
Ketamine for Treatment Resistant Late-Life DepressionNCT02556606 · VA Office of Research and Development	Completed	Phase 3	ketamine	1
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing TonsillectomyNCT02987985 · University of Saskatchewan	Completed	Phase 3	ketamine	1
Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)NCT02397889 · Icahn School of Medicine at Mount Sinai	Completed	Phase 2 / Phase 3	ketamine	1
Biomarkers of Response to Ketamine in Depression: MRI and Blood Assays Before and After Open Label Intranasal KetamineNCT04216888 · Dan Iosifescu	Completed	Phase 2 / Phase 3	ketamine	1
Ketamine Infusion for Comorbid PTSD and Chronic PainNCT04322968 · VA Ann Arbor Healthcare System	Completed	Phase 3	ketamine	1
Ketamine and Postoperative Depressive Symptom-PASSIONNCT03086148 · Beijing Tiantan Hospital	Completed	Phase 2 / Phase 3	ketamine	1
The Effect of Ketamine on Mechanises Underlying Suicidal Ideation and Drug-resistant Major DepressionNCT02037503 · Tel-Aviv Sourasky Medical Center	Unknown status	Phase 3	ketamine	1
Study on the Use of Low Dose Ketamine After Gastric Bypass and GastrectomyNCT02452060 · NYU Langone Health	Completed	Phase 2 / Phase 3	ketamine	1
Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency DepartmentNCT03436121 · Maria Pacella	Withdrawn	Phase 2 / Phase 3	ketamine	—
Endogenous Opioid Modulation by KetamineNCT03051945 · University of Utah	Withdrawn	Phase 3	ketamine	1
Ketamine as an Alternative Treatment to ECT in Major Depressive DisorderNCT02659085 · Pouya Movahed Rad	Completed	Phase 2 / Phase 3	ketamine	1
Evaluation of Schemes of Administration of Intravenous Ketamine in DepressionNCT03742557 · National Institute of Neurology and Neurosurgery, Mexico	Unknown status	Phase 3	ketamine	1
A Study to Decrease Suicidal Thinking Using KetamineNCT02418702 · United States Naval Medical Center, San Diego	Withdrawn	Phase 3	ketamine	1
Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of PainNCT03915938 · Hospital de Clinicas de Porto Alegre	Completed	Phase 2 / Phase 3	ketamine	—
Action of Ketamine in Treatment-Resistant DepressionNCT01945047 · University of Ottawa	Completed	Phase 2 / Phase 3	ketamine	1
Lamotrigine for Ketamine Dependence TrialNCT02556060 · Taipei City Hospital	Completed	Phase 2 / Phase 3	ketamine	1
Intranasal Ketamine In the Treatment of Pediatric Bipolar DisorderNCT01504659 · Juvenile Bipolar Research Foundation	Terminated	Phase 2 / Phase 3	ketamine	4
The Impact of Ketamine on the Reward Circuitry of Suicidal PatientsNCT02532153 · Massachusetts General Hospital	Withdrawn	Phase 3	ketamine	1
Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six WeeksNCT01557712 · University Hospital, Grenoble	Completed	Phase 3	ketamine	1
Emergency Ketamine Treatment of Suicidal IdeationNCT02183272 · University of Cincinnati	Unknown status	Phase 2 / Phase 3	ketamine	1
To Test the Potential Efficacy of Repeated Intranasal Administration of Ketamine as a Treatment for PTSDNCT02398136 · Adriana Feder	Withdrawn	Phase 2 / Phase 3	ketamine	—
An Open Prospective Trial of IV Ketamine in Suicidal AdolescentsNCT02048423 · Nationwide Children's Hospital	Unknown status	Phase 2 / Phase 3	ketamine	1
Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent PatientNCT00329394 · University Hospital, Clermont-Ferrand	Suspended	Phase 3	ketamine	1

All records from ClinicalTrials.gov API v2, data build 2026-08-25. Registry records change between builds; the NCT number on each row links to the authoritative version.