Psilocybin for Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Psilocybin for the Treatment of Major Depressive Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05675800
• Other study ID #: 202209153
• Secondary ID: R25MH112473
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2023
• Source: Washington University School of Medicine
• Contact: Demetrius Perry
• Phone: 314-747-5514
• Email: perry.demetrius[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: March 31, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Psilocybin
Psilocybin administered with psychological support

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adverse Events	Rates of adverse events related to treatment, as determined by multiple data collection mechanisms	Up to 12 weeks post-treatment
Primary	Study Retention and Completion	Rates of successful attendance of study visits and completion of study	Throughout study participation (12-17 weeks)
Secondary	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