NCT06796361 (PDR) is a Phase 1 clinical trial of Ketanserin 40mg plus Psilocybin 40mg in Healthy, sponsored by University Hospital, Basel, Switzerland.

Who is sponsoring NCT06796361?

NCT06796361 is sponsored by University Hospital, Basel, Switzerland.

What drugs are being tested in NCT06796361?

Interventions in NCT06796361: Ketanserin 40mg plus Psilocybin 40mg, 40mg Psilocybin, 20mg Psilocybin, 10mg Psilocybin, 5mg Psilocybin, Placebo.

Is NCT06796361 still recruiting?

NCT06796361 is currently recruiting now. Last updated 26 May 2025.

Last reviewed 2025-05-26 · How we verify

NCT06796361: PDR

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

Role of the Serotonin 2A Receptor in Psilocybin-induced Altered States of Consciousness (PDR-Study)

Recruiting now Phase 1 Last updated 26 May 2025

What this trial tests

Phase 1 trial testing Ketanserin 40mg plus Psilocybin 40mg in Healthy in 16 participants. Currently enrolling.

Timeline

21 April 2025

Primary endpoint
1 August 2026

1 August 2026

Quick facts

Lead sponsor	University Hospital, Basel, Switzerland
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	basic science
Enrollment	16
Start date	21 April 2025
Primary completion	1 August 2026
Estimated completion	1 August 2026
Sites	1 location across Switzerland

Drugs / interventions tested

Ketanserin 40mg plus Psilocybin 40mg — full drug profile →
40mg Psilocybin — full drug profile →
20mg Psilocybin — full drug profile →
10mg Psilocybin — full drug profile →
5mg Psilocybin — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

University Hospital, Basel, Switzerland

Who can join

Adults 25 to 75, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

5 dimensions of altered state of consciousness (5D-ASC) total OAV score
Time frame: 10 hours after substance administration
Visual analog scale consisting of 94 items. Constructed of five scales and allows assessing mood, anxiety, derealization, depersonalization, changes in perception, auditory alterations, and reduced vigilance. Scales will be presented as 100 mm long horizontal lines marked with vertical lines by the participant.

Sponsor's own description

Psilocybin (active compound of "magic mushrooms") is a prototypical psychedelic substance that acts via agonism on serotonin (5-HT) 2A receptors. Psilocybin is rapidly metabolized into its active metabolite psilocin. Psilocybin is currently under investigation as potential treatment for various neuropsychiatric disorders. Psilocybin is also widely used for recreational purposes and as research tool in neuroscience. Besides its current clinical development, a clear characterization of the dose-response relationship of psilocybin is lacking. With the present study the investigators aim to close this knowledge gap by administering low (5mg) to high (40mg) single doses of psilocybin to healthy participants. Besides its agonism on 5-HT2A receptors, psilocin also binds to other receptors and inhibits serotonin transporters (SERT). To this data only few studies have investigated these effects and never at a high dose.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Other University Hospital, Basel, Switzerland trials

Trials by the same sponsor.

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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 NCT06796361 (US National Library of Medicine, public domain)
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 Hospital, Basel, Switzerland
Last refreshed: 26 May 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/NCT06796361.

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