Depression is the most heavily studied indication in psychedelic medicine. Psilocybin programs for treatment-resistant depression and major depressive disorder have advanced through Phase II into Phase III, with additional research into LSD, DMT analogues, and short-acting tryptamines. This page lists every depression-related trial PoliPsy tracks from ClinicalTrials.gov, with phase, recruitment status, sponsor, and start date.
| Trial | Drug | Phase | Status | Sponsor | Conditions | Start date |
|---|---|---|---|---|---|---|
| Group PACBT for Depression | Psilocybin | Phase 2 | Not Yet Recruiting | University of California, Los Angeles | Depression - Major Depressive Disorder, Psilocybin, Cognitive Behavioral Therapy | Jan 1, 2027 |
| ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder | Psilocybin | Phase 1 | Not Yet Recruiting | University of Minnesota | Borderline Personality Disorder, Borderline Personality Pathology, Depressive Symptoms, Emotion Dysregulation, Suicidal Ideation | Dec 1, 2026 |
| Shortened LSD Intervention for Major Depressive Disorder | LSD | Phase 1 | Not Yet Recruiting | Johns Hopkins University | Major Depression Moderate, Major Depression Severe, Major Depression | Oct 1, 2026 |
| Psilocybin-Assisted Therapy for Intergenerational Trauma | Psilocybin | Phase 2 | Recruiting | Rachel Yehuda | Psychological Stress, Depression, Anxiety | Aug 28, 2026 |
| Psilocybin to Treat Depression in Spinal Cord Injury | Psilocybin | Phase 1 / Phase 2 | Recruiting | James J. Peters Veterans Affairs Medical Center | Spinal Cord Injury, Depression - Major Depressive Disorder, Veteran | Aug 6, 2026 |
| Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression | Psilocybin | Phase 3 | Recruiting | VA Office of Research and Development | Major Depression | Aug 3, 2026 |
| A Mechanistic Study to Assess a Single Dose of CYB003 in Participants With Depression and Anxiety | Multiple | Phase 2 | Recruiting | Ohio State University | Depression, Anxiety, Major Depressive Disorder | Aug 1, 2026 |
| Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder | Psilocybin | Phase 1 / Phase 2 | Not Yet Recruiting | Indiana University | Treatment Resistant Depression, Substance Use Disorders | Aug 1, 2026 |
| The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease | Psilocybin | Phase 2 | Recruiting | Yale University | Depression, Parkinson's Disease (PD) | Jul 10, 2026 |
| Mindfulness-based Psilocybin Therapy for PTSD | Psilocybin | Phase 2 | Recruiting | Anthony P King | Post Traumatic Stress Disorder, Depression - Major Depressive Disorder | Jul 1, 2026 |
| Study of Psilocybin Under Anesthesia Controlled by EEG | Psilocybin | Phase 2 | Not Yet Recruiting | Stanford University | Major Depression | Jul 1, 2026 |
| Psilocybin-Assisted Therapy as a Treatment for Depression | Psilocybin | Phase 2 | Not Yet Recruiting | Washington University School of Medicine | Depression | Jun 1, 2026 |
| Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies | Psilocybin | Phase 2 | Active Not Recruiting | University of Washington | Anxiety, Depression, Hematopoietic and Lymphatic System Neoplasm, Metastatic Malignant Solid Neoplasm | May 19, 2026 |
| A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend) | Psilocybin | Phase 3 | Recruiting | Definium Therapeutics US, Inc. | Major Depressive Disorder | May 10, 2026 |
| Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression | Psilocybin | N/A | Recruiting | Massachusetts General Hospital | Treatment Resistant Depression (TRD) | Apr 17, 2026 |
| RCT of Psilocybin-assisted CBT for Depression | Psilocybin | Phase 1 / Phase 2 | Recruiting | University of California, Los Angeles | Major Depressive Diorder | Jan 5, 2026 |
| Psilocybin-Assisted Therapy for the Treatment of Major Depressive Disorder in Patients With Non-Small Cell Lung Cancer | Psilocybin | Phase 2 | Recruiting | Alan Davis | Lung Non-Small Cell Carcinoma, Unipolar Depression | Jan 1, 2026 |
| A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder | Multiple | Phase 3 | Recruiting | Cybin IRL Limited | Major Depressive Disorder (MDD), Depression in Adults, Depression - Major Depressive Disorder, Depression Disorders, Depression Disorder, Depression | Dec 10, 2025 |
| Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression | Psilocybin | Phase 2 | Recruiting | VA Office of Research and Development | Chronic Low Back Pain, Depression | Dec 3, 2025 |
| Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND) | Psilocybin | Phase 3 | Enrolling By Invitation | Cybin IRL Limited | Major Depressive Disorder | Jul 18, 2025 |
| Acceptability & Safety of Two Sequential Doses of Psilocybin in Bipolar Disorder II Depression and Suicidality | Psilocybin | Phase 2 | Recruiting | The University of Texas Health Science Center, Houston | Bipolar II Disorder, Depression, Bipolar, Suicidality | Jul 7, 2025 |
| Mood Effects of Serotonin Agonists: Depression | LSD | Early Phase 1 | Completed | University of Chicago | LSD, Major Depressive Disorder, Depression | Jun 9, 2025 |
| TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors | Psilocybin | Phase 2 | Recruiting | M.D. Anderson Cancer Center | Depression, Anxiety, Cancer | May 23, 2025 |
| Investigation to Understand and Optimize Psilocybin | Psilocybin | Phase 2 | Recruiting | Charles Raison | Depression | May 13, 2025 |
| A Phase 3 Trial of MM120 for Major Depressive Disorder (Emerge) | Psilocybin | Phase 3 | Active Not Recruiting | Definium Therapeutics US, Inc. | Major Depressive Disorder | Apr 14, 2025 |
| Study of the Safety, Tolerability, Electrophysiological Effects and Efficacy of DMT in Humans | DMT | Phase 1 | Recruiting | Deepak C. D'Souza | Major Depression Disorder, Depression | Mar 14, 2025 |
| Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder | Psilocybin | Phase 2 | Recruiting | Icahn School of Medicine at Mount Sinai | Major Depressive Disorder | Feb 25, 2025 |
| Psilocybin rTMS for Treatment Resistant Depression | Psilocybin | Phase 2 | Recruiting | University of Texas at Austin | Treatment Resistant Depression, MDD, Major Depressive Disorder, Recurrent Depression, Depression | Jan 10, 2025 |
| "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder" | Multiple | Phase 3 | Active Not Recruiting | Cybin IRL Limited | Major Depressive Disorder | Dec 17, 2024 |
| Computer Game, Qualitative, and MEG/EEG Assessment of Serotonergic Psychedelics | Multiple | N/A | Terminated | Yale University | OCD, Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD), Healthy Volunteer, Migraine, PTSD, PTSD - Post Traumatic Stress Disorder, Addiction, Tobacco Use Disorder, Obsessive Compulsive Disorder (OCD), Opioid Use Disorder | Dec 12, 2024 |
| Open-Label Psilocybin Study in Transdiagnostic Population | Psilocybin | Phase 1 | Recruiting | Yale University | Transdiagnostic, Depression - Major Depressive Disorder, Anxiety, PTSD Symptoms, PTSD, Substance Use, Substance Use Disorder (SUD), OCD | Oct 17, 2024 |
| The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder | Psilocybin | Phase 3 | Recruiting | Sharmin Ghaznavi | Major Depressive Disorder | Sep 10, 2024 |
| Psilocybin Therapy for Depression in Parkinson's Disease | Psilocybin | Phase 2 | Recruiting | Joshua Woolley, MD, PhD | Parkinson Disease, Depression | Aug 19, 2024 |
| Low-Income Group Psilocybin Assisted Therapy for Depression | Psilocybin | N/A | Completed | Matthew Hicks | Depression | Aug 1, 2024 |
| Psilocybin for Treatment-Resistant Depression | Psilocybin | Phase 2 | Completed | University of Colorado, Denver | Major Depressive Disorder, Anhedonia, Treatment Resistant Depression | Jul 8, 2024 |
| Mindful Self-Compassion to Address PTSD and Substance Use in Unhoused Women | Psilocybin | N/A | Completed | University of California, Los Angeles | Posttraumatic Stress Disorder (PTSD), Anxiety, Depression - Major Depressive Disorder | May 5, 2024 |
| Psilocybin in Chronic Low Back Pain and Depression | Psilocybin | Phase 1 | Recruiting | Johns Hopkins University | Chronic Low-back Pain, Depression | Apr 22, 2024 |
| Psilocybin-Assisted Therapy in Treatment-Resistant Depression | Psilocybin | Phase 3 | Active Not Recruiting | University of North Carolina, Chapel Hill | Refractory Depression, Treatment Resistant Depression | Apr 19, 2024 |
| Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy | Psilocybin | Phase 2 | Recruiting | M.D. Anderson Cancer Center | Depression, Anxiety, Psilocybin-Assisted Psychotherapy, Advanced Cancer | Apr 16, 2024 |
| Psilocybin for Major Depressive Disorder (MDD) | Psilocybin | Phase 3 | Active Not Recruiting | Usona Institute | Depressive Disorder, Major | Mar 13, 2024 |
| Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder | Psilocybin | Phase 2 | Completed | University of Chicago | Borderline Personality Disorder, Major Depressive Disorder | Nov 1, 2023 |
| Two Doses of Psilocybin for the Treatment of MDD in Adults With Cancer | Psilocybin | Phase 2 | Active Not Recruiting | Sunstone Medical | Cancer, Major Depressive Disorder | Oct 23, 2023 |
| Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults | DMT | Phase 1 | Unknown | Advanced Integrative Medical Science Institute | Major Depression, Post Traumatic Stress Disorder | Oct 1, 2023 |
| BPL-003 Efficacy and Safety in Treatment Resistant Depression | DMT | Phase 2 | Completed | Beckley Psytech Limited | Treatment Resistant Depression | Sep 14, 2023 |
| PET Synaptogenesis After Psilocybin In DEpression Recovery | Psilocybin | Phase 2 | Withdrawn | Washington University School of Medicine | Major Depressive Disorder, Anhedonia | Jul 1, 2023 |
| Psilocybin-assisted CBT for Depression | Psilocybin | Phase 1 | Completed | University of California, Los Angeles | Major Depressive Disorder | Jun 27, 2023 |
| Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD | Psilocybin | Phase 3 | Active Not Recruiting | COMPASS Pathways | Treatment Resistant Depression | Feb 14, 2023 |
| A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder | Psilocybin | Phase 2 | Active Not Recruiting | COMPASS Pathways | Major Depressive Disorder | Jan 30, 2023 |
| Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD | Psilocybin | Phase 3 | Completed | COMPASS Pathways | Treatment Resistant Depression | Jan 24, 2023 |
| PAPR: PAP + MBSR for Front-line Healthcare Provider COVID-19 Related Burnout | Psilocybin | Phase 1 | Completed | University of Utah | Depression, Burnout, Professional | Jan 2, 2023 |
| The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD | Psilocybin | Phase 2 | Withdrawn | Massachusetts General Hospital | Treatment-Resistant Major Depressive Disorder | Sep 15, 2022 |
| A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder | Multiple | Phase 1 / Phase 2 | Completed | Cybin IRL Limited | Major Depressive Disorder | Aug 2, 2022 |
| Trifecta Research Study | Multiple | N/A | Active Not Recruiting | Axial Therapeutic Research | PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction, Brain Injury, Depression - Major Depressive Disorder, Suicidal Ideation | Aug 1, 2022 |
| The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation | Psilocybin | Phase 2 | Completed | Sheppard Pratt Health System | Treatment Resistant Depression, Suicidal Ideation | Mar 28, 2022 |
| Frontline Clinician Psilocybin Study | Psilocybin | Phase 3 | Completed | University of Washington | Burnout, Caregiver, Burnout, Professional, COVID-19, Depression, Post Traumatic Stress Disorder, Moral Injury | Mar 3, 2022 |
| Psilocybin Therapy for Depression in Bipolar II Disorder | Psilocybin | Phase 2 | Active Not Recruiting | University of California, San Francisco | Bipolar II Disorder | Jan 28, 2022 |
| Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease | Psilocybin | Phase 2 | Completed | Joshua Woolley, MD, PhD | Parkinson Disease, Depression, Anxiety | Aug 15, 2021 |
| Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder | Psilocybin | Phase 2 | Active Not Recruiting | Johns Hopkins University | Major Depressive Disorder, Alcohol Use Disorder | Apr 14, 2021 |
| Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease | Psilocybin | Early Phase 1 | Recruiting | Johns Hopkins University | Depressive Symptoms, Depression, Alzheimer Disease, Mild Cognitive Impairment | Mar 24, 2021 |
| Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans | DMT | Phase 1 | Active Not Recruiting | Yale University | Major Depressive Disorder, Depression | Mar 17, 2021 |
| An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD) | Psilocybin | Phase 2 | Unknown | Sheppard Pratt Health System | Treatment Resistant Depression | Mar 1, 2021 |
| The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression. | Psilocybin | Phase 2 | Unknown | Sheppard Pratt Health System | Treatment Resistant Depression | Mar 1, 2021 |
| The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder | Psilocybin | Phase 2 | Unknown | Maryland Oncology Hematology, PA | Major Depressive Disorder | Sep 1, 2020 |
| The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression | Psilocybin | Phase 2 | Completed | COMPASS Pathways | Treatment Resistant Depression | Aug 10, 2020 |
| Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU) | Psilocybin | N/A | Completed | COMPASS Pathways | Treatment Resistant Depression | Jul 20, 2020 |
| PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder | Psilocybin | N/A | Terminated | Usona Institute | Major Depressive Disorder | Jun 30, 2020 |
| A Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping With Mental Health | Psilocybin | Phase 4 | Completed | Field Trip Health | Depression, Anxiety, Post Traumatic Stress Disorder | Mar 13, 2020 |
| A Study of Psilocybin for Major Depressive Disorder (MDD) | Psilocybin | Phase 2 | Completed | Usona Institute | Depressive Disorder, Major | Jan 23, 2020 |
| The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression | Psilocybin | Phase 2 | Completed | COMPASS Pathways | Treatment Resistant Depression | Mar 1, 2019 |
| Project PRIDE (Promoting Resilience In Discriminatory Environments) | Psilocybin | N/A | Completed | University of Houston | Human Immunodeficiency Virus, Sexually Transmitted Infections, Anxiety, Depression, Substance Use Disorders | Nov 9, 2018 |
| Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder | Psilocybin | Phase 1 | Active Not Recruiting | Yale University | Major Depressive Disorder | Feb 27, 2018 |
| Effects of an 8-day Advanced Meditation, Samyama on Physical, Psychological and Spiritual Wellbeing ,and Associated Neural Mechanisms | MDMA | N/A | Completed | Indiana University | Mental Health Wellness 1, Happiness, Depression, Consciousness, Level Altered, Ecstasy, Dietary Habits, Stress, Inflammatory Bowel Diseases | Jan 19, 2018 |
| Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors | Psilocybin | Phase 1 | Completed | Joshua Woolley | Distress, Depression, Grief | Jan 5, 2018 |
| Pilot Study Comparing Two Versions of Group Cognitive-behavioral Indicated Prevention Programs | Psilocybin | N/A | Completed | Oregon Research Institute | Depressive Symptoms | Oct 10, 2017 |
| Effects of Psilocybin in Major Depressive Disorder | Psilocybin | Phase 2 | Completed | Johns Hopkins University | Major Depressive Disorder | Aug 10, 2017 |
| IMPAACT 2002: Cognitive Behavioral Therapy and Medication Management for Treatment of Depression in US Youth With HIV | Psilocybin | N/A | Completed | International Maternal Pediatric Adolescent AIDS Clinical Trials Group | HIV, Depression | Mar 6, 2017 |
| Psychopharmacology of Psilocybin in Cancer Patients | Psilocybin | Phase 2 | Completed | Johns Hopkins University | Depressive Symptoms, Anxiety, Cancer | Apr 1, 2007 |
Psychedelic Clinical Trials for PTSD · Psychedelic Clinical Trials for Addiction · Psychedelic Clinical Trials for Anxiety · All psychedelic clinical trials
Psilocybin accounts for most depression research, with additional studies of LSD, DMT and 5-MeO-DMT analogues, and short-acting tryptamines. Programs cover both treatment-resistant depression and major depressive disorder.
Psilocybin for treatment-resistant depression has reached Phase III, the final stage typically required before an FDA new drug application. It also holds Breakthrough Therapy designation, which accelerates FDA review but does not guarantee approval.
Each listing links to its ClinicalTrials.gov record with eligibility criteria, study sites, and investigator contacts. Screening and enrollment are handled entirely by the research team — PoliPsy does not recruit participants.
No. Psilocybin remains a Schedule I substance federally and is not FDA approved for depression. It is legally available only through authorized research or state-regulated supervised access programs in Oregon and Colorado.
Trials typically use one or two supervised dosing sessions paired with preparatory and integration psychotherapy, rather than a daily medication. Participants are monitored for the full duration of each session.