NCT04739865

The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: COMPASS Pathways · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression

Detailed description

A recent open label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid significant decrease of depressive symptoms after treatment with psilocybin coupled with psychological support. Over 40% of participants sustained response at 3 months. In this study, the aim is to explore effectiveness of 25 mg of psilocybin as an adjunctive therapy in participants with TRD.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	Psilocybin	Open label

Timeline

• Start date: 2020-08-10
• Primary completion: 2021-10-14
• Completion: 2021-10-14
• First posted: 2021-02-05
• Last updated: 2023-11-09
• Results posted: 2023-11-09

Locations

2 sites across 2 countries: United States, Ireland

Regulatory

• FDA-regulated drug study