Last reviewed · How we verify
NCT03715127
Clinical, Neurocognitive, and Emotional Effects of Psilocybin in Depressed Patients - Proof of Concept
Phase 2 trial testing Psilocybine oral capsule in Depressive Disorder, Major in 55 participants. Completed in 12 April 2022.
12 October 2021
Quick facts
| Lead sponsor | University of Zurich |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 11 March 2019 |
| Primary completion | 12 October 2021 |
| Estimated completion | 12 April 2022 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Psilocybine oral capsule
- Placebo oral capsule
Conditions studied
- Depressive Disorder, Major — all drugs for Depressive Disorder, Major →
Sponsor
University of Zurich
Who can join
Adults 18 to 60, any sex, with Depressive Disorder, Major. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Effects of serotonin 2A/1A receptor stimulation by psilocybin on mood and emotion processing in major depressive disorder: a randomized double-blind placebo-controlled study
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial.
von Rotz R, Schindowski EM, Jungwirth J, Schuldt A, et al · · 2023 · cited 188× · PMID 36636296 · DOI 10.1016/j.eclinm.2022.101809 -
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 -
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 -
Rethinking Therapeutic Strategies for Anorexia Nervosa: Insights From Psychedelic Medicine and Animal Models.
Foldi CJ, Liknaitzky P, Williams M, Oldfield BJ. · · 2020 · cited 33× · PMID 32116500 · DOI 10.3389/fnins.2020.00043 -
Novel Antidepressants in the Pipeline (Phase II and III): A Systematic Review of the US Clinical Trials Registry.
Sakurai H, Yonezawa K, Tani H, Mimura M, et al · · 2022 · cited 21× · PMID 35045580 · DOI 10.1055/a-1714-9097 -
What is the clinical evidence on psilocybin for the treatment of psychiatric disorders? A systematic review.
Castro Santos H, Gama Marques J. · · 2021 · cited 20× · PMID 33884324 · DOI 10.1097/j.pbj.0000000000000128 -
The Use of Psychedelics in the Treatment of Medical Conditions: An Analysis of Currently Registered Psychedelics Studies in the American Drug Trial Registry.
Kurtz JS, Patel NA, Gendreau JL, Yang C, et al · · 2022 · cited 19× · PMID 36259015 · DOI 10.7759/cureus.29167
Verify or expand the search:
- PubMed search for NCT03715127
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Depressive Disorder, Major
Currently open trials in the same condition.
- NCT07227454 — A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder · Phase 3 · recruiting
- NCT07258485 — A Study to Evaluate Sleep Electroencephalogram (EEG) Features (Brain Activity While Sleeping) in Participants With Major · recruiting
- NCT07059234 — The Motor Activity - Subjective Energy (MASE) Project · NA · recruiting
- NCT06982820 — Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia · NA · recruiting
- NCT05553353 — Dosing rTMS for Depression Post-SCI · NA · recruiting
Other University of Zurich trials
Trials by the same sponsor.
- NCT07485699 — Soy Processing and Food Allergy · NA · not yet recruiting
- NCT07516912 — Evaluation of Free STI Testing Pilot Projects in Lucerne and Zurich, Switzerland · not yet recruiting
- NCT07473115 — Individualized Analgesia in the Intensive Care Unit With a New Pain Assessment Bundle and Protocolized Analgesia Adjustm · not yet recruiting
- NCT07524023 — Emotional-distress-based Integrated Care Programme in Patients With Stable COPD · NA · recruiting
- NCT06481982 — Value of Advanced MRI Techniques in the Assessment of Endometriosis · withdrawn
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 NCT03715127 (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 Zurich
- Last refreshed: 29 April 2022
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/NCT03715127.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing