The Safety and Efficacy of Psilocybin in Participants Wit... | NCT04433845

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

NCT04433845

Sponsor

Sheppard Pratt Health System

Status

Unknown status

Last Update Posted

Oct 25, 2022Actual

Enrollment

15Actual

Phase

Phase 2

Conditions

Treatment Resistant Depression

Interventions

Psilocybin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Jan 15, 2023Estimated

Completion Date

Apr 15, 2023Estimated

First Submitted Date

Jun 13, 2020

First Submission Date that Met QC Criteria

Jun 13, 2020

First Posted Date

Jun 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2022

Last Update Posted Date

Oct 25, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Scott T. Aaronson, M.D, Director, Clinical Research Programs, Sheppard Pratt Health SystemPrincipal Investigator

Lead Sponsor

Sheppard Pratt Health SystemOTHER

Collaborators

Name	Class
COMPASS Pathways	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psilocybin	Experimental	25mg of Psilocybin	Drug: Psilocybin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psilocybin	Drug	Open-label	Psilocybin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Comorbidities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott Aaronson, MD	Sheppard Pratt Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheppard Pratt		Baltimore	Maryland	21204	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D061218	Depressive Disorder, Treatment-Resistant

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011562	Psilocybin

Ancestor Terms

ID	Term
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles

Browse Leaves

Not provided

Browse Branches

Not provided