NCT04433845

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

1.9 years

First QC Date

June 13, 2020

Last Update Submit

October 24, 2022

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

  • 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

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

Study Arms (1)

Psilocybin

EXPERIMENTAL

25mg of Psilocybin

Drug: Psilocybin

Interventions

PsilocybinDRUG

Open-label

Psilocybin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression

You may not qualify if:

  • Comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheppard Pratt

Baltimore, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Indole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTryptaminesIndolizidinesIndolizines

Study Officials

  • Scott Aaronson, MD

    Sheppard Pratt Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Research Programs

Study Record Dates

First Submitted

June 13, 2020

First Posted

June 16, 2020

Study Start

March 1, 2021

Primary Completion

January 15, 2023

Study Completion

April 15, 2023

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)