Effect of SSRIs on Response to Psilocybin Therapy

This open-label, single-arm trial (n=30) aimed to evaluate the effect of length of time on selective serotonin reuptake inhibitors (SSRIs) on the response to psilocybin-assisted therapy in individuals with mild-moderate Major Depressive Disorder (MDD).

All participants received a single dose of 25mg of psilocybin in a therapeutic setting. The study enrolled individuals with varying lengths of time on SSRI therapy, stratified into four groups based on the duration of SSRI treatment.

The primary outcome measure was assessed using the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), with secondary outcomes including response and remission rates, depression severity measured by MADRS, and safety assessments. The study started on January 1, 2023, and was expected to be completed by March 14, 2023, but was ultimately withdrawn.

Topic Depression
Compound Psilocybin
Country Canada
Visit trial
Status Withdrawn
Results Published No
Start date 01 January 2023
End date 14 March 2023
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 0
Sex All
Age 19- 65
Therapy Yes

Trial Details

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

NCT Number NCT05594667

Sponsors & Collaborators

Cybin
Cybin is a for-profit company that aims to deliver psychedelics (psilocybin) via a sublingual delivery mechanism. The company aims to start clinical trials within the year (2021). It has raised $98 million US.

Data attribution

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