Psilocybin for Anhedonia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Anhedonia+3 More
Psilocybin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Participants with depression will be given a single dose of psilocybin and supportive psychotherapy before, during, and after drug administration. Participants will undergo positron emission tomography (PET) imaging before and one week after psilocybin using a marker of synaptic density. This design allows us to assess the relationship between neurotrophic, and antidepressant effects produced by psilocybin.

Eligible Conditions
  • Major Depressive Disorder (MDD)
  • Anhedonia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Anhedonia

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 7 days after psilocybin

7 days after psilocybin
Anhedonia
Unipolar Depression
Magnetic Resonance Imaging
Synaptogenesis in hippocampus
Synaptogenesis in medial prefrontal cortex

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Anhedonia

Side Effects for

Psilocybin
44%Headache
21%Nausea
15%Anxiety
8%Suicidal Ideation
6%Insomnia
6%Depressed mood
4%Alcohol poisoning
4%Pneumonia
4%Viral upper resp. tract infection
4%Depression
4%Corona virus infection
4%Vomiting
4%Upper respiratory tract infection
4%Abdominal pain upper
2%Musculoskeletal pain
2%Dizziness
2%Pain
2%Limb injury
2%Abdominal pain
2%Blood pressure increased
2%Urinary incontinence
2%Cataract
2%Testicular pain
2%Toothache
2%Illusion
2%Fatigue
2%Psychomotor hyperactivity
2%Skin cosmetic procedure
2%Food allergy
2%Muscle strain
2%Back pain
2%Food poisoning
2%Alcohol withdrawal syndrome
2%Dysphoria
2%Nasal congestion
2%Photopsia
2%Myalgia
2%Palpitations
2%Dyspepsia
2%Biopsy cervix
2%Gingivitis
2%Diverticulitis
2%Asthenia
2%Influenza
2%Oropharyngeal pain
2%Hyperventilation
2%Blood pressure diastolic increased
2%Dyspnea
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02061293) in the Psilocybin ARM group. Side effects include: Headache with 44%, Nausea with 21%, Anxiety with 15%, Suicidal Ideation with 8%, Insomnia with 6%.

Trial Design

1 Treatment Group

Psilocybin
1 of 1
Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: Psilocybin · No Placebo Group · Phase 2

Psilocybin
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~560

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days after psilocybin

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,789 Previous Clinical Trials
2,271,852 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of childbearing age and you must agree to be on two forms of contraception.
You are willing to comply with all study requirements, including psychological, cognitive, and imaging for the duration of the study.
You have major depressive disorder and a current depressive episode.
You have a score of 6 or more on the Snaith-Hamilton Anhedonia Pleasure Scale.
You are willing and able to taper and/or discontinue current psychotropic medications.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
California66.7%
Texas33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Washington University School of Medicine100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
050.0%
3+50.0%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Washington University School of Medicine: < 24 hours
Average response time
  • < 1 Day