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Psilocybin and Depression

NCT ID: NCT03380442

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2021-09-30

Brief Summary

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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

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Conditions

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Severe Depression

Keywords

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fMRI psilocybin ketamine biomarker rapid-acting antidepressants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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).

Study Groups

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Psilocybin group

This group will receive a single oral 25mg dose of psilocybin under surveilled and safe conditions.

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

Psilocybin ingested orally

Ketamine group

This group will receive a single intranasal 125mg dose of ketamine under surveilled and safe conditions.

Group Type ACTIVE_COMPARATOR

Ketamine (Ketalar)

Intervention Type DRUG

Ketamine administered intranasally

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psilocybin

Psilocybin ingested orally

Intervention Type DRUG

Ketamine (Ketalar)

Ketamine administered intranasally

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Tomi Rantamäki, Laboratory of Neurotherapeutics, Department of Biosciences, University of Helsinki

UNKNOWN

Sponsor Role collaborator

Dr. Robin Carthart-Harris and Prof. David Nutt, Imperial College London, UK

UNKNOWN

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Jesper Ekelund

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mona E Moisala, PhD

Role: CONTACT

Phone: 504480044

Email: [email protected]

Other Identifiers

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2016-004195-22

Identifier Type: -

Identifier Source: org_study_id