Psilocybin and Depression

NCT03380442 | Unknown Phase 2

• 1 other identifier: 2016-004195-22
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Depression

Keywords

fMRI; psilocybin; ketamine; biomarker; rapid-acting antidepressants

Outcome Measures

Primary Outcomes (1)

• The 16-Item Quick Inventory of Depressive Symptomatology (QIDS)

  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.

  6 months

Secondary Outcomes (2)

• The Montgomery and Asberg Depression Rating Scale

  3 months

• Hamilton Depression Rating Scale

  3 months

Study Arms (3)

Psilocybin group

EXPERIMENTAL

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

Drug: Psilocybin

Ketamine group

ACTIVE COMPARATOR

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

Drug: Ketamine (Ketalar)

No-treatment group

NO INTERVENTION

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

Interventions

Psilocybin DRUG

Psilocybin ingested orally

Psilocybin group

Ketamine (Ketalar) DRUG

Ketamine administered intranasally

Ketamine group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Current or previously diagnosed psychotic disorder.
• Immediate family member with a diagnosed psychotic disorder.
• Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure etc.).
• History of suicide attempts.
• History of mania.
• Current 5-HT2A antagonist antidepressant medication.
• Blood or needle phobia.
• Positive pregnancy test.
• Current drug or alcohol dependence.
• Lack of appropriate use of contraception.
• Breast-feeding.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Depression

Interventions

Psilocybin; Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Mona E Moisala, PhD

CONTACT

504480044; mona.moisala@helsinki.fi

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 21, 2017
• Study Start: September 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: September 1, 2021
• Last Updated: December 21, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share