Psilocybin for Major Depressive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psilocybin Active Dose Treatment A

Psilocybin

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

Psilocybin administered with psychological support

Psilocybin Active Dose Treatment B

Psilocybin

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

Psilocybin administered with psychological support

Interventions

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Psilocybin

Psilocybin administered with psychological support

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No