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Psilocybin and Depression (Psilo101)

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ClinicalTrials.gov Identifier: NCT03380442
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : December 21, 2017
Sponsor:
Collaborators:
Dr. Tomi Rantamäki, Laboratory of Neurotherapeutics, Department of Biosciences, University of Helsinki
Dr. Robin Carthart-Harris and Prof. David Nutt, Imperial College London, UK
Information provided by (Responsible Party):
Jesper Ekelund, University of Helsinki

Tracking Information
First Submitted Date  ICMJE December 12, 2017
First Posted Date  ICMJE December 21, 2017
Last Update Posted Date December 21, 2017
Estimated Study Start Date  ICMJE September 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
The 16-Item Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: 6 months ]
The primary outcome measures in this study will be the mean change in QIDS scores from pre-administration baseline at day 1 to Follow-up 2 at day 103 (3 months after the administration session). Additionally, an electronic version of the QIDS will be performed 6 months after the administration session. The criteria for determining response will be a reduction of 25% in the (QIDS; Rush et al., 2003) scores from baseline (screening), and remission will be scores of ≤5 on the QIDS.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2017)
  • The Montgomery and Asberg Depression Rating Scale [ Time Frame: 3 months ]
    The Montgomery and Asberg Depression Rating Scale will be carried out at screening ( day 1), Follow-up 1 (day 18) and Follow-up 2 (day 103, 3 months after the administration session).
  • Hamilton Depression Rating Scale [ Time Frame: 3 months ]
    The Hamilton Depression Rating Scale will be carried out at screening ( day 1), Follow-up 1 (day 18) and Follow-up 2 (day 103, 3 months after the administration session).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin and Depression
Official Title  ICMJE Psilocybin and Depression - Assessing the Long-term Effects of a Single Administration of Psilocybin on the Psychiatric Symptoms and Brain Activity of Patients With Severe Depression
Brief Summary The main aim of the study is to investigate the possible long-term therapeutic effects of psilocybin on the symptoms of severe depression, as well as the brain mechanisms underlying these changes. Depression severity is assessed before and after (i.e., 1 week, 3 months and 6 months after) a single dose of psilocybin and compared to respective scores of a group receiving an active placebo, ketamine. Brain activity (using functional magnetic resonance imaging) is measured before and one week after drug administration in order to determine whether changes in brain networks related to emotional and self-referential processing correlate with any observed changes in depression scores. Further, blood samples will be obtained from the participants and analyzed in order to reveal gene expression and molecular level correlates underlying rapid antidepressant effects, and to identify biomarkers that predict treatment outcome.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
In a randomized, double-blind placebo-controlled design, 20 of the participants will receive ketamine, and 20 will receive psilocybin. 20 of the participants will be included in the study as a no-treatment group, so that natural time-dependent changes in depressive symptoms can be controlled for and thus the antidepressive effects of ketamine and psilocybin treatment can be verified. The no-treatment group will only attend the initial clinical interviews, and their depressive symptoms will be assessed remotely.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Since the psilocybin is ingested orally in capsule form, whereas ketamine is administered intranasally, the participants will either receive a placebo capsule containing microcrystalline cellulose (if they belong to the group receiving ketamine), or intranasally administered saline solution (with added bitter flavoring which will mimic the taste of ketamine that is often detectable even when administered intranasally).
Primary Purpose: Basic Science
Condition  ICMJE Severe Depression
Intervention  ICMJE
  • Drug: Psilocybin
    Psilocybin ingested orally
  • Drug: Ketamine (Ketalar)
    Ketamine administered intranasally
Study Arms  ICMJE
  • Experimental: Psilocybin group
    This group will receive a single oral 25mg dose of psilocybin under surveilled and safe conditions.
    Intervention: Drug: Psilocybin
  • Active Comparator: Ketamine group
    This group will receive a single intranasal 125mg dose of ketamine under surveilled and safe conditions.
    Intervention: Drug: Ketamine (Ketalar)
  • No Intervention: No-treatment group
    This group will be included in the study as a no-treatment group, so that natural time-dependent changes in depressive symptoms can be controlled for and thus the antidepressive effects of ketamine and psilocybin treatment can be verified
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 15, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Major depression of a moderate to severe degree (17+ on the 21-item HAM-D).
  2. No health-related contraindications.

Exclusion Criteria:

  1. Current or previously diagnosed psychotic disorder.
  2. Immediate family member with a diagnosed psychotic disorder.
  3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc.).
  4. History of suicide attempts.
  5. History of mania.
  6. Current 5-HT2A antagonist antidepressant medication.
  7. Blood or needle phobia.
  8. Positive pregnancy test.
  9. Current drug or alcohol dependence.
  10. Lack of appropriate use of contraception.
  11. Breast-feeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mona E Moisala, PhD 504480044 ext +358 mona.moisala@helsinki.fi
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03380442
Other Study ID Numbers  ICMJE 2016-004195-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jesper Ekelund, University of Helsinki
Study Sponsor  ICMJE University of Helsinki
Collaborators  ICMJE
  • Dr. Tomi Rantamäki, Laboratory of Neurotherapeutics, Department of Biosciences, University of Helsinki
  • Dr. Robin Carthart-Harris and Prof. David Nutt, Imperial College London, UK
Investigators  ICMJE Not Provided
PRS Account University of Helsinki
Verification Date December 2017

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