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Effect of SSRIs on Response to Psilocybin Therapy

NCT05594667 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-07-06

No results posted yet for this study

Summary

This study is an open-label, single-arm, within-subjects design in individuals with mild-moderate Major Depressive Disorder (MDD). All participants will receive a single dose of 25mg of psilocybin in a therapeutic setting. In order to investigate the effects of length of time on SSRI therapy, 30 participants with varying lengths of time on SSRI therapy will be enrolled, stratified into four groups:

* Group 1: ≤ 1 year
* Group 2: 1 to ≤ 5 years
* Group 3: 5 to ≤ 10 years
* Group 4: \> 10 years

Conditions

Interventions

DRUG

Psilocybin

25mg of psilocybin provided by Filament Health

Sponsors & Collaborators

  • Cybin Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Reginald Peters, MD · Upstream

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-03-14
Completion
2023-03-14

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05594667 on ClinicalTrials.gov