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Psychedelic

Psilocybin for Low Mood (SnS Trial)

Phase 2

Waitlist Available

Led By Jennifer Mitchell, PhD

Research Sponsored by Robin Carhart-Harris, PhD, MA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be between 21 and 70 years of age

Participants must be able to swallow pills/capsules

Must not have

Participants with immediate family members with a current or previously diagnosed psychotic disorder or bipolar disorder

Participants currently taking specific medications or substances or engaging in excessive use of alcohol or drugs of abuse

Timeline

Screening 3 weeks

Treatment Varies

Follow Up eight hours post-dose.

Summary

This trial will involve 120 healthy individuals between the ages of 21 and 70 who have moderate-to-lower-than-average mental well-being. They will be divided into four groups and given either a

Who is the study for?

This trial is for healthy individuals aged 21 to 70 who feel their mental well-being is moderate to low. Participants must not have any serious health issues and should be interested in how different environments might influence the effects of psilocybin, a substance being studied for its potential to improve mood.

What is being tested?

The study tests if the setting affects how psilocybin works on mood. One group gets a placebo (no active drug), while others get up to 25mg of psilocybin. They're placed in one of two different contexts designed to see if environment changes the drug's impact.

What are the potential side effects?

Psilocybin can cause headaches, nausea, increased heart rate, blood pressure changes, psychological distress or confusion temporarily during use. The specific side effects may vary depending on the context it's taken in.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 70 years old.

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I can swallow pills or capsules.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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A close family member has had bipolar disorder or a psychotic disorder.

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I am not using excessive alcohol, drugs, or certain medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose; 2, 4, and 6 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose; 2, 4, and 6 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose; 2, 4, and 6 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Challenging Experience Questionnaire (CEQ) subscales score

Change in Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) score from Baseline to 28 days post-dose

Change in Watts Connectedness Scale (WCS) scores from Baseline to 28 days post-dose

+1 more

Secondary study objectives

Acute Lempel Ziv Complexity (LZC) via Electroencephalography (EEG)

Changes in BOLD activity during emotional processing via functional magnetic resonance imaging (fMRI)

Changes in resting state BOLD activity viafunctional magnetic resonance imaging (fMRI)

+6 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Psilocybin C2Experimental Treatment2 Interventions

Following screening and a baseline assessment visit, healthy volunteers will receive one dose of up to 25mg psilocybin in a context (Context 2) that is hypothesized to modulate acute and post-acute drug effects.

Group II: Psilocybin C1Experimental Treatment2 Interventions

Following screening and a baseline assessment visit, healthy volunteers will receive one dose of up to 25mg psilocybin in a context (Context 1) that is hypothesized to modulate acute and post-acute drug effects.

Group III: Placebo C1Placebo Group2 Interventions

Following screening and a baseline assessment visit, healthy volunteers will receive one dose of an inactive placebo in a context (Context 1) that is hypothesized to modulate acute and post-acute drug effects.

Group IV: Placebo C2Placebo Group2 Interventions

Following screening and a baseline assessment visit, healthy volunteers will receive one dose of an inactive placebo in a context (Context 2) that is hypothesized to modulate acute and post-acute drug effects.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~530

0 / 4Eligibility criteria met