Psilocybin for Major Depressive Disorder

The Washington University

Status and phase: Withdrawn; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Psilocybin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05675800

202209153

R25MH112473 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Psilocybin Active Dose Treatment A

Experimental group

Description:

Psilocybin

Treatment:

Drug: Psilocybin

Psilocybin Active Dose Treatment B

Experimental group

Description:

Psilocybin

Treatment:

Drug: Psilocybin