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

Phase 2Active Not RecruitingNCT04433858

Sheppard Pratt Health System27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Treatment Resistant Depression

Interventions

PsilocybinDRUG

open-label

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of at least moderate Major Depressive Disorder (MDD) Exclusion Criteria: * Comorbidities Note for CA site: Only Veterans are Eligible

Locations (2)

VA Palo Alto Healthcare System/Stanford Medicine

Palo Alto, California, United States

Sheppard Pratt Health System

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Montgomery Asberg Depression Rating Scale (MADRS)

MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = \>50% decrease and Remission =\< 10 actual score.

Time frame: From Baseline (Day -1) to three weeks post-dose.

Data from ClinicalTrials.gov

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