The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

Sheppard Pratt Health System15 enrolled

Overview

The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, 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 Type 2 Bipolar Disorder (BP-II) Depression Exclusion Criteria: * Comorbidities

Locations (1)

Sheppard Pratt

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

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.