Health TrialsbyHealthPanel

The Neurobiological Effect of 5-HT2AR Modulation

ConditionBasic Science
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGitte Moos Knudsen

About this trial

The investigators wish to investigate neurobiological effects of serotonin 2A receptor modulation in healthy volunteers, contrasting effects of an agonist (psilocybin) and an antagonist (ketanserin). Magnetic resonance imaging (MRI) and positron emission tomography (PET) will be used as neuroimaging tools.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Presence of or previous primary psychiatric disease (DSM axis 1 or WHO ICD-10 diagnostic classifications) or in first-degree relatives.

Previous or present neurological condition/disease, significant somatic condition/disease or intake of drugs suspected to influence test results.

Non-fluent Danish language skills.

Vision or hearing impairment.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Psilocybine

    Drug

    Oral dose of psilocybine.

  • Ketanserin

    Drug

    Oral dose of ketanserin.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Project 1: Occupancy of psilocybin/ketanserinOther 2 interventions
Group B: Project 2: Long term effects of psilocybinOther 1 intervention
Group C: Project 3: Functional connectivityOther 2 interventions

Trial outcomes

Primary outcomes

1

Psilocin/ketanserin blood concentrations and 5-HT2A receptor occupancy (i.e., binding potential).

The investigators aim to model relations psilocin/ketanserin blood drug concentrations and receptor occupancy, using C11-Cimbi-36 PET imaging.

Time frame
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).
2

Effects of psilocybin on Cimbi-36 binding potential at baseline and at one and twelve weeks

Cimbi-36 PET scan binding potential at baseline and at one-week post psilocybin, and potentially also at 12 weeks post psilocybin.

Time frame
Change in Cimbi-36 binding potential from baseline to one week post psilocybin (and potentially also at 12 weeks after psilocybin).
3

Effects of psilocybin and ketanserin on brain function assessed with fMRI and PET

Correlations between blood levels of ketanserin and psilocin and the estimated associated receptor occupancy with functional MRI neuroimaging data, including resting state networks. Changes in synaptic density will be assessed with 11C-UCB-J PET scans before and 1 week after psilocybin intervention.

Time frame
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)
4

Effects of psilocybin on UCB-J binding potential at baseline and at one week

Project 2, Subproject B. UCB-J PET scan binding potential at baseline and at one-week post psilocybin.

Time frame
Change in UCB-J binding potential from baseline to one week post psilocybin.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gitte Moos Knudsen

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Source ClinicalTrials.gov
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