NCT05601648

Brief Summary

Participants with depression will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo positron emission tomography (PET) imaging before and one week after psilocybin using a marker of synaptic density. This design allows us to assess the relationship between neurotrophic, and antidepressant effects produced by psilocybin.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Typical duration for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

October 17, 2022

Last Update Submit

January 26, 2023

Conditions

Major Depressive DisorderAnhedonia

Keywords

Psilocybin11C-UCB-JSV2A

Outcome Measures

Primary Outcomes (2)

  • Synaptogenesis in hippocampus

    Change in 11C-UCB-J signal in the hippocampus from baseline to post-treatment PET scans.

    7 days after psilocybin

  • Synaptogenesis in medial prefrontal cortex

    Change in 11C-UCB-J signal in the medial prefrontal cortex from baseline to post-treatment PET scans.

    7 days after psilocybin

Secondary Outcomes (2)

  • Change in major depressive disorder symptoms

    7 days after psilocybin

  • Change in anhedonia symptoms

    7 days after psilocybin

Other Outcomes (1)

  • Limbic functional connectivity, measured with resting state functional MRI

    7 days after psilocybin

Study Arms (1)

Psilocybin

EXPERIMENTAL

Eligible adults to undergo a single drug session with psilocybin (25mg tablet) plus supportive psychotherapy

Drug: Psilocybin

Interventions

PsilocybinDRUG

Psilocybin (25mg tablet) plus supportive psychotherapy

Psilocybin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between 18 and 65 years of age;
  • Able to provide informed consent
  • Women of childbearing age must agree to be on two forms of contraception and men are required to utilize at least one form of contraception
  • Willingness to comply and be available for all study requirements, including psychological, cognitive, and imaging for the duration of the study
  • Meeting DSM-5 criteria for major depressive disorder and current depressive episode
  • Snaith-Hamilton Anhedonia Pleasure Scale (SHAPS) ≥ 6 points
  • Willing and able to taper and/or discontinue current psychotropic medications

You may not qualify if:

  • Women who are pregnant or who intend to become pregnant or nurse during the study duration.
  • Presence of psychiatric conditions that are contraindications to psilocybin exposure (e.g., personal or first degree relative with history of schizophrenia spectrum or bipolar disorder);
  • Use of psychotropic medication that may interact with psilocybin (TCA, MAOi, antipsychotic/neuroleptics, anti-epileptic/mood stabilizer, lithium, SSRI, SNRI, Mirtazapine, Buproprion, Vortioxetine).
  • Recent use of psychedelics (psilocybin, LSD, ayahuasca, mescaline; past 5 years); or prior severe adverse reactions to psychedelics
  • Active suicidal ideation or history of a suicide attempt.
  • Presence of medical conditions that are contraindications to psilocybin exposure (e.g., neurological conditions or severe hypertension, severe and/or unstable metabolic or cardiovascular conditions);
  • Current medical conditions that are known to increase risk of severe coronavirus infection or deemed by a study physician to put an individual at high risk (i.e., cancer, COPD, obesity, immunosuppression, type 2 diabetes, serious heart conditions, sickle cell disease, asthma);
  • Presence of contraindications to PET or MRI scanning (renal disease, implantable devices, bone hardware, some IUDs);
  • Body mass index \>30 (due to MRI confounds).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorAnhedonia

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTryptaminesIndolizidinesIndolizines
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label treatment study, no placebo.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2022

First Posted

November 1, 2022

Study Start

July 1, 2023

Primary Completion

January 1, 2025

Study Completion

July 1, 2025

Last Updated

January 30, 2023

Record last verified: 2023-01

Locations

US(1)