Who is sponsoring NCT06341426?

NCT06341426 is sponsored by University Health Network, Toronto.

What drugs are being tested in NCT06341426?

Interventions in NCT06341426: Single Psychedelic Dose Psilocybin, Two Psychedelic Doses Psilocybin.

What condition does NCT06341426 study?

NCT06341426 studies Major Depressive Disorder, Depression, Treatment-Resistant Depression, Mood Disorders.

Is NCT06341426 still recruiting?

NCT06341426 is currently recruiting now. Last updated 2 April 2024.

Last reviewed 2024-04-02 · How we verify

NCT06341426: PSI-1V2

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

Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin

Recruiting now Phase 2 Last updated 2 April 2024

What this trial tests

Phase 2 trial testing Single Psychedelic Dose Psilocybin in Major Depressive Disorder in 92 participants. Currently enrolling.

Timeline

5 February 2024

Primary endpoint
1 February 2028

1 August 2028

Quick facts

Lead sponsor	University Health Network, Toronto
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	92
Start date	5 February 2024
Primary completion	1 February 2028
Estimated completion	1 August 2028
Sites	1 location across Canada

Drugs / interventions tested

Single Psychedelic Dose Psilocybin — full drug profile →
Two Psychedelic Doses Psilocybin — full drug profile →

Conditions studied

Major Depressive Disorder — all drugs for Major Depressive Disorder →
Depression — all drugs for Depression →
Treatment-Resistant Depression — all drugs for Treatment-Resistant Depression →
Mood Disorders — all drugs for Mood Disorders →

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered.

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 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 Health Network, Toronto trials

Trials by the same sponsor.

NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
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NCT06836726 — Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resis · Phase 2 · not yet recruiting
NCT07515651 — Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas · Phase 2 · not yet recruiting
NCT07509450 — Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cel · 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 NCT06341426 (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 Health Network, Toronto
Last refreshed: 2 April 2024

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/NCT06341426.

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