Last reviewed · How we verify
NCT05259943
Microdosing Psychedelics to Improve Mood
Phase 2 trial testing Psilocybin first in Major Depressive Disorder in 39 participants. Completed in 1 February 2025.
21 December 2024
Quick facts
| Lead sponsor | Rotem Petranker |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 39 |
| Start date | 15 July 2023 |
| Primary completion | 21 December 2024 |
| Estimated completion | 1 February 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Psilocybin first — full drug profile →
- Placebo first — full drug profile →
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Rotem Petranker — full company profile →
Who can join
Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial aims to examine the safety and efficacy of small (2mg) sub-hallucinogenic doses of psilocybin in people with Major Depressive Disorder.
Publications & conference data
3 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 -
Safety and Efficacy of Microdosing Psilocybin over 8 Weeks for Major Depressive Disorder: A Randomized Clinical Trial
Petranker R, Farb N, Syed O, Li E, et al · · 2026 · DOI 10.21203/rs.3.rs-8319478/v1 -
Microdosing psilocybin for major depressive disorder: study protocol for a phase II double-blind placebo-controlled randomised partial crossover trial.
Beidas Z, Ragnhildstveit A, Blackman A, Anderson T, et al · · 2026 · PMID 41693474 · DOI 10.1192/bjo.2025.10968
Verify or expand the search:
- PubMed search for NCT05259943
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Major Depressive Disorder
Currently open trials in the same condition.
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- 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
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05259943 (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 Rotem Petranker
- Last refreshed: 30 December 2025
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/NCT05259943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing