NCT06230757 is a Phase 2 clinical trial of Psilocybin 25mg in Major Depressive Disorder, sponsored by University of Colorado, Denver.

Who is sponsoring NCT06230757?

NCT06230757 is sponsored by University of Colorado, Denver.

What drugs are being tested in NCT06230757?

Interventions in NCT06230757: Psilocybin 25mg, Placebo (active placebo).

What condition does NCT06230757 study?

NCT06230757 studies Major Depressive Disorder, Anhedonia, Treatment Resistant Depression.

Is NCT06230757 still recruiting?

NCT06230757 is currently active, enrolled. Last updated 21 January 2026.

Last reviewed 2026-01-21 · How we verify

NCT06230757

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

Psilocybin for Treatment-Resistant Depression

Active, enrolled Phase 2 Last updated 21 January 2026

What this trial tests

Phase 2 trial testing Psilocybin 25mg in Major Depressive Disorder in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 July 2024

Primary endpoint
1 March 2026

1 March 2026

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	8 July 2024
Primary completion	1 March 2026
Estimated completion	1 March 2026
Sites	1 location across United States

Drugs / interventions tested

Psilocybin 25mg — full drug profile →
Placebo (active placebo)

Conditions studied

Major Depressive Disorder — all drugs for Major Depressive Disorder →
Anhedonia — all drugs for Anhedonia →
Treatment Resistant Depression — all drugs for Treatment Resistant Depression →

Sponsor

University of Colorado, Denver

Who can join

Adults 21 to 75, any sex, with Major Depressive Disorder or Anhedonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the efficacy of psilocybin on the symptom of anhedonia in individuals with treatment-resistant major depressive disorder.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Emerging Medications for Treatment-Resistant Depression: A Review with Perspective on Mechanisms and Challenges.
Lucido MJ, Dunlop BW. · · 2025 · cited 7× · PMID 40002494 · DOI 10.3390/brainsci15020161

Verify or expand the search:

Other trials of Psilocybin 25mg

Trials testing the same drug.

NCT06888128 — State-Funded Trial Assessing Recovery and Long-Term Impact of Guided Psilocybin for Healing Trauma · Phase 2 · 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 University of Colorado, Denver trials

Trials by the same sponsor.

NCT07292285 — The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial. · not yet recruiting
NCT07021937 — Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity · Phase 3 · not yet recruiting
NCT07453732 — Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients. · NA · not yet recruiting
NCT07038278 — 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma · EARLY_PHASE1 · not yet recruiting
NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · 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 NCT06230757 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 University of Colorado, Denver
Last refreshed: 21 January 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/NCT06230757.

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