An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

Sheppard Pratt Health System

Status and phase: Active, not recruiting; Phase 2

Conditions: Treatment Resistant Depression

Treatments: Drug: Psilocybin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04433858

14947563

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of at least moderate Major Depressive Disorder (MDD)

Exclusion criteria

• Comorbidities

Note for CA site: Only Veterans are Eligible

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Psilocybin

Experimental group

Description:

25mg of Psilocybin Note: CA site only is re-dosing participants with an exacerbation in depressive symptoms at a minimum of 12 months post-initial dosing.

Treatment:

Drug: Psilocybin