Psilocybin for Major Depressive Disorder | NCT05675800

Studies
Psilocybin for Major Depressive Disorder

NCT05675800

Sponsor

Washington University School of Medicine

Status

Withdrawn

Last Update Posted

Jul 25, 2024Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Major Depressive Disorder

Interventions

Psilocybin

Countries

Not provided

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

ID	Type	Description	Link
R25MH112473	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Resident who was tasked with coordinating this study is no longer able to do so.

Expanded Access Info

Start Date

Jan 1, 2024Estimated

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Nov 22, 2022

First Submission Date that Met QC Criteria

Jan 6, 2023

First Posted Date

Jan 9, 2023Actual

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

Jul 23, 2024

Last Update Posted Date

Jul 25, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ginger E Nicol, Associate Professor of Psychiatry, Washington University School of MedicinePrincipal Investigator

Lead Sponsor

Washington University School of MedicineOTHER

Collaborators

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

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 goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psilocybin Active Dose Treatment A	Experimental	Psilocybin	Drug: Psilocybin
Psilocybin Active Dose Treatment B	Experimental	Psilocybin	Drug: Psilocybin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psilocybin	Drug	Psilocybin administered with psychological support	Psilocybin Active Dose Treatment A Psilocybin Active Dose Treatment B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline	Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms	3 weeks post-treatment
Adverse Events	Rates of adverse events related to treatment, as determined by multiple data collection mechanisms	Up to 12 weeks post-treatment
Study Retention and Completion	Rates of successful attendance of study visits and completion of study	Throughout study participation (12-17 weeks)

Secondary Outcomes

Measure	Description	Time Frame
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline	Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms	12 weeks post-treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Currently meeting DSM-V Criteria for a Major Depressive Episode of at least mild-moderate severity
Aged 18-85
Ability and willingness to attend study visits and complete study assessments

Exclusion Criteria:

Presence of medical conditions at screening that may affect the safe administration of psilocybin (including, but not limited to: AST/ALT > 150, QTc > 450ms, MELD > 9)
Depression deemed secondary to a severe medical condition
Recent use of any classical psychedelic drug or MDMA
Recent use of any interventional psychiatric treatment (including: ECT, ketamine, esketamine, TMS)
Intention to begin any new treatment for depression prior to primary outcome determination
Use of any excluded medication
Active substance use disorder
Presence of any psychiatric condition that may interfere with the safe administration of psilocybin
Active suicidal ideation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 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
Ginger Nicol, MD	Washington University School of Medicine	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study protocol and analysis plan will be publicly available on publication of the research. Individual researchers can request individual participant data collected during the trial, after deidentification, for specifically outlined research-related purposes upon publication.

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Upon publication, indefinitely

Access Criteria

Investigators with a research plan that is reviewed and approved by the P.I.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

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