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

S

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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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