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Trial record 8 of 31 for:    psilocybin

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, Helsinki University

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.

Condition or disease Intervention/treatment Phase
Severe Depression Drug: Psilocybin Drug: Ketamine (Ketalar) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: 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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Psilocybin group
This group will receive a single oral 25mg dose of psilocybin under surveilled and safe conditions.
Drug: Psilocybin
Psilocybin ingested orally

Active Comparator: Ketamine group
This group will receive a single intranasal 125mg dose of ketamine under surveilled and safe conditions.
Drug: Ketamine (Ketalar)
Ketamine administered intranasally

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380442


Contacts
Contact: Mona E Moisala, PhD 504480044 ext +358 mona.moisala@helsinki.fi

Sponsors and Collaborators
Helsinki University
Dr. Tomi Rantamäki, Laboratory of Neurotherapeutics, Department of Biosciences, University of Helsinki
Dr. Robin Carthart-Harris and Prof. David Nutt, Imperial College London, UK

Additional Information:
Responsible Party: Jesper Ekelund, Professor of Psychiatry, Helsinki University
ClinicalTrials.gov Identifier: NCT03380442     History of Changes
Other Study ID Numbers: 2016-004195-22
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jesper Ekelund, Helsinki University:
fMRI
psilocybin
ketamine
biomarker
rapid-acting antidepressants

Additional relevant MeSH terms:
Psilocybin
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hallucinogens
Psychotropic Drugs