The Neurobiological Effect of 5-HT2AR Modulation
NCT03289949 · NeuroPharm2 · Gitte Moos Knudsen
What it is testing
Summary
Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.
What counts as success
Primary outcome measures
Psilocin/ketanserin blood concentrations and 5-HT2A receptor occupancy (i.e., binding potential).
Measured over Change in Cimbi-36 binding potential from baseline PET to intervention PET 1 and PET 2 scans (same day for psilocybin, and two consecutive days for ketanserin).
Effects of psilocybin on Cimbi-36 binding potential at baseline and at one and twelve weeks
Measured over Change in Cimbi-36 binding potential from baseline to one week post psilocybin (and potentially also at 12 weeks after psilocybin).
Effects of psilocybin and ketanserin on brain function assessed with fMRI and PET
Measured over Changes in functional connectivity (fMRI) from Baseline MR to intervention MR scans for ketanserin (one or three weeks after baseline MR) and psilocybin (one or three weeks after baseline)
Effects of psilocybin on UCB-J binding potential at baseline and at one week
Measured over Change in UCB-J binding potential from baseline to one week post psilocybin.
Effects of psilocybin on brain function assessed with fMRI at baseline and one month
Measured over Change in fMRI measures from baseline to one month post psilocybin
Anxiety Outcome Measure 1: Acute psychological effects as assessed using Challenging Experiences Questionnaire (CEQ).
Measured over Immediately post-intervention.
Anxiety Outcome Measure 2: Acute psychological effects as assessed using 5D-Altered States of Consciousness (5D-ASC) scale.
Measured over Immediately post-intervention.
Anxiety Outcome Measure 3: Acute psychological effects as assessed using Extended Subjective Drug Intensity (eSDI) scale.
Measured over During intervention.
Transformative Experiences Outcome Measure 1: Acute psychological effects as assessed using Mystical Type Experiences Questionnaire (MEQ) scale.
Measured over Immediately post-intervention.
Transformative Experiences Outcome Measure 2: Acute psychological effects as assessed using Psychological Insights Questionnaire (PIQ) scale.
Measured over Immediately post-intervention.
Transformative Experiences Outcome Measure 3: Acute psychological effects as assessed using Emotional Breakthrough Questionnaire (EBI) scale.
Measured over Immediately post-intervention.
Persisting Effects Outcome Measure 1: Persisting psychological effects as assessed using Persisting Effects Questionnaire (PEQ) scale.
Measured over One and three months post-intervention.
A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.
Who can take part
Eligibility, as published
Where
1 study site
| Facility | City | Region | Country |
|---|---|---|---|
| Neurobiology Research Unit, Rigshospitalet | Copenhagen | — | Denmark |
On the registry
Contact the trial directly
This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.
Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.
NCT03289949 on ClinicalTrials.gov →
Last updated in the registry 2024-12-16. Registry records change; this page reflects the data build of 2026-08-25.
Related
Where this trial sits
Substance
Indication