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The Neurobiological Effect of 5-HT2AR Modulation

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ClinicalTrials.gov Identifier: NCT03289949
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Gitte Moos Knudsen, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE September 21, 2017
Last Update Posted Date August 13, 2020
Actual Study Start Date  ICMJE March 3, 2017
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2020)
  • Psilocin/ketanserin blood concentrations and 5-HT2A receptor occupancy (i.e., binding potential). [ 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). ]
    The investigators aim to model relations psilocin/ketanserin blood drug concentrations and receptor occupancy, using C11-Cimbi-36 PET imaging.
  • Effects of psilocybin on Cimbi-36 binding potential at baseline and at one and twelve weeks [ Time Frame: Change in Cimbi-36 binding potential from baseline to one week post psilocybin (and potentially also at 12 weeks after psilocybin). ]
    Cimbi-36 PET scan binding potential at baseline and at one-week post psilocybin, and potentially also at 12 weeks post psilocybin.
  • Effects of psilocybin and ketanserin on brain function assessed with fMRI and PET [ 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) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
  • Psilocin/ketanserin blood concentrations and 5-HT2A receptor occupancy (i.e., binding potential). [ 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). ]
    The investigators aim to model relations psilocin/ketanserin blood drug concentrations and receptor occupancy, using C11-Cimbi-36 PET imaging.
  • Effects of psilocybin on Cimbi-36 binding potential at baseline and at one and twelve weeks [ Time Frame: Change in Cimbi-36 binding potential from baseline to one week post psilocybin (and potentially also at 12 weeks after psilocybin). ]
    Cimbi-36 PET scan binding potential at baseline and at one-week post psilocybin, and potentially also at 12 weeks post psilocybin.
  • Effects of psilocybin and ketanserin on brain function assessed with fMRI [ 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) ]
    Correlations between blood levels of ketanserin and psilocin and the estimated associated receptor occupancy with functional MRI neuroimaging data, including resting state networks
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Neurobiological Effect of 5-HT2AR Modulation
Official Title  ICMJE The Neurobiological Effect of 5-HT2AR Modulation
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Basic Science
Intervention  ICMJE
  • Drug: Psilocybine
    Oral dose of psilocybine.
    Other Name: Psilocybin
  • Drug: Ketanserin
    Oral dose of ketanserin.
    Other Name: Ketensin
Study Arms  ICMJE
  • Project 1: Occupancy of psilocybin/ketanserin
    After baseline MRI & 5-HT2AR PET-imaging, participants will be allocated to undergo either one oral dose of psilocybine or one oral dose of ketanserin. After drug administration, participants will undergo two CIMBI-36 PET scans.
    Interventions:
    • Drug: Psilocybine
    • Drug: Ketanserin
  • Project 2: Long term effects of psilocybin
    After baseline MRI & CIMBI-36 PET-imaging, participants will receive one dose of oral psilocybine intervention. One and 12 weeks after dosing, participants will undergo post-intervention PET-scan.
    Intervention: Drug: Psilocybine
  • Project 3: Functional connectivity and synaptic plasticity
    After baseline MRI scanning and CIMBI-36 PET, participants will undergo one psilocybine-intervention fMRI scan and one ketanserin-intervention fMRI scan. If P2 shows there are long term effects of psilocybine on 5-HT2AR levels, psilocybine will be fixed as the second intervention. If not, interventions will be randomized.
    Interventions:
    • Drug: Psilocybine
    • Drug: Ketanserin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2017)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1) Healthy individuals above 18 years of age.

Exclusion Criteria:

  1. Presence of or previous primary psychiatric disease (DSM axis 1 or WHO ICD-10 diagnostic classifications) or in first-degree relatives.
  2. Previous or present neurological condition/disease, significant somatic condition/disease or intake of drugs suspected to influence test results.
  3. Non-fluent Danish language skills.
  4. Vision or hearing impairment.
  5. Previous or present learning disability.
  6. Pregnancy.
  7. Breastfeeding.
  8. Contraindications in regard to MRI scanning.
  9. Alcohol or drug abuse.
  10. Allergy to test drugs.
  11. Participation in studies in which participant has received more than 10 mSv of radiation or other significant exposure to radiation.
  12. Abnormal ECG or intake of QT prolonging medication.
  13. Previous significant side-effects in regard to hallucinogenic drugs.
  14. Use of hallucinogenic drugs 6 months previous to inclusion.
  15. Blood donation 3 months before and after project participation
  16. Bodyweight under 50 kg.
  17. Plasma ferritin levels outside normal range
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Gitte M Knudsen, Professor +45 35456720 gmk@nru.dk
Contact: Martin K Madsen, MD +45 35456708 martin@nru.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03289949
Other Study ID Numbers  ICMJE 2016-004000-61
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Via database of Center for Integrated Molecular Brain Imaging (Knudsen et al 2016, NeuroImage) data will be available for neuroscience research community contingent on approval by scientific board.
Responsible Party Gitte Moos Knudsen, Rigshospitalet, Denmark
Study Sponsor  ICMJE Gitte Moos Knudsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Gitte M Knudsen, Professor Neurobiology Research Unit, Rigshospitalet
PRS Account Rigshospitalet, Denmark
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP