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NCT03715127

Clinical, Neurocognitive, and Emotional Effects of Psilocybin in Depressed Patients - Proof of Concept

Completed Phase 2 Last updated 29 April 2022
What this trial tests

Phase 2 trial testing Psilocybine oral capsule in Depressive Disorder, Major in 55 participants. Completed in 12 April 2022.

Timeline
11 March 2019
Primary endpoint
12 October 2021
12 April 2022

Quick facts

Lead sponsorUniversity of Zurich
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment55
Start date11 March 2019
Primary completion12 October 2021
Estimated completion12 April 2022
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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:

Other recruiting trials for Depressive Disorder, Major

Currently open trials in the same condition.

Other University of Zurich trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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