NCT05594667

Effect of SSRIs on Response to Psilocybin Therapy

Withdrawn Phase 2 Last updated 6 July 2023

What this trial tests

Phase 2 trial testing Psilocybin in Depression. Withdrawn.

Timeline

1 January 2023

Primary endpoint
14 March 2023

14 March 2023

Quick facts

Lead sponsor	Cybin Therapeutics Inc.
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 January 2023
Primary completion	14 March 2023
Estimated completion	14 March 2023
Sites	1 location across Canada

Drugs / interventions tested

• Psilocybin — full drug profile →

Conditions studied

• Depression — all drugs for Depression →
• Major Depressive Disorder — all drugs for Major Depressive Disorder →
• Mild Depression — all drugs for Mild Depression →
• Moderate Depression — all drugs for Moderate Depression →

Sponsor

Cybin Therapeutics Inc.

Who can join

Adults 19 to 65, any sex, with Depression or Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The possible place for psychedelics in pharmacotherapy of mental disorders.
   Wojtas A. · · 2023 · cited 7× · PMID 37934320 · DOI 10.1007/s43440-023-00550-9