NCT04620759 (PsiloMDDAUD) is a Phase 2 clinical trial of Psilocybin in Major Depressive Disorder, sponsored by Johns Hopkins University.

Who is sponsoring NCT04620759?

NCT04620759 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT04620759?

Interventions in NCT04620759: Psilocybin, Placebo.

What condition does NCT04620759 study?

NCT04620759 studies Major Depressive Disorder, Alcohol Use Disorder.

Is NCT04620759 still recruiting?

NCT04620759 is currently active, enrolled. Last updated 13 March 2026.

Last reviewed 2026-03-13 · How we verify

NCT04620759: PsiloMDDAUD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder

Active, enrolled Phase 2 Last updated 13 March 2026

What this trial tests

Phase 2 trial testing Psilocybin in Major Depressive Disorder in 90 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 April 2021

Primary endpoint
2 March 2026

30 March 2027

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	90
Start date	14 April 2021
Primary completion	2 March 2026
Estimated completion	30 March 2027
Sites	1 location across United States

Drugs / interventions tested

Psilocybin — full drug profile →
Placebo

Conditions studied

Major Depressive Disorder — all drugs for Major Depressive Disorder →
Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Johns Hopkins University

Who can join

Adults 21 to 65, any sex, with Major Depressive Disorder or Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine whether psilocybin, a hallucinogenic drug, is effective in reducing depressive symptoms and amount of drinking in patients with co-occurring Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The future of psychopharmacology: a critical appraisal of ongoing phase 2/3 trials, and of some current trends aiming to de-risk trial programmes of novel agents.
Correll CU, Solmi M, Cortese S, Fava M, et al · · 2023 · cited 90× · PMID 36640403 · DOI 10.1002/wps.21056
Therapeutic effect of psilocybin in addiction: A systematic review.
van der Meer PB, Fuentes JJ, Kaptein AA, Schoones JW, et al · · 2023 · cited 55× · PMID 36846225 · DOI 10.3389/fpsyt.2023.1134454
Psychedelic Therapy's Transdiagnostic Effects: A Research Domain Criteria (RDoC) Perspective.
Kelly JR, Gillan CM, Prenderville J, Kelly C, et al · · 2021 · cited 36× · PMID 34975593 · DOI 10.3389/fpsyt.2021.800072
Clinical specificity profile for novel rapid acting antidepressant drugs.
Scala M, Fanelli G, De Ronchi D, Serretti A, et al · · 2023 · cited 33× · PMID 37381161 · DOI 10.1097/yic.0000000000000488
Psychedelic therapies reconsidered: compounds, clinical indications, and cautious optimism.
Mitchell JM, Anderson BT. · · 2024 · cited 32× · PMID 37479859 · DOI 10.1038/s41386-023-01656-7
Classic psychedelics and alcohol use disorders: A systematic review of human and animal studies.
Calleja-Conde J, Morales-García JA, Echeverry-Alzate V, Bühler KM, et al · · 2022 · cited 31× · PMID 36301215 · DOI 10.1111/adb.13229
Psychedelic Targeting of Metabotropic Glutamate Receptor 2 and Its Implications for the Treatment of Alcoholism.
Domanegg K, Sommer WH, Meinhardt MW. · · 2023 · cited 18× · PMID 36980303 · DOI 10.3390/cells12060963
Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial.
Vanderijst L, Hever F, Buot A, Dauré C, et al · · 2024 · cited 6× · PMID 38279085 · DOI 10.1186/s12888-024-05502-y

Verify or expand the search:

Other trials of Psilocybin

Trials testing the same drug.

NCT06885996 — Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence · Phase 2 · not yet recruiting
NCT07499583 — Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder · Phase 1, PHASE2 · not yet recruiting
NCT07226232 — Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression · Phase 3 · not yet recruiting
NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
NCT07506395 — Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder · Phase 1 · not yet recruiting

Other recruiting trials for Major Depressive Disorder

Currently open trials in the same condition.

NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting

Other Johns Hopkins University trials

Trials by the same sponsor.

NCT06236542 — Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety · NA · not yet recruiting
NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04620759 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 13 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04620759.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing