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Psychedelic

Psilocybin for Depression (PET-SPIDER Trial)

Phase 2
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after psilocybin
Awards & highlights

PET-SPIDER Trial 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
  • Depression
  • Anhedonia

PET-SPIDER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after psilocybin
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after psilocybin for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Synaptogenesis in hippocampus
Synaptogenesis in medial prefrontal cortex
Secondary outcome measures
Anhedonia
Unipolar Depression
Other outcome measures
Magnetic Resonance Imaging

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Insomnia
4%
Suicidal Ideation
4%
Influenza
4%
Oropharyngeal pain
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Pyrexia
2%
Vomiting
2%
Musculoskeletal pain
2%
Oedema
2%
Restlessness
2%
Peripheral swelling
2%
Hypoesthesia
2%
Rhinorrhea
2%
Fungal infection
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

PET-SPIDER Trial Design

1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
Eligible adults to undergo a single drug session with psilocybin (25mg tablet) plus supportive psychotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,930 Previous Clinical Trials
2,299,396 Total Patients Enrolled
69 Trials studying Depression
23,379 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety measures are in place to protect individuals who take Psilocybin?

"Despite limited data validating the efficacy of Psilocybin, there is evidence that suggests it is relatively safe. As such, we have assigned a score of 2 to this substance according to our internal rating system."

Answered by AI

Are there any remaining opportunities for individuals to join this research trial?

"As per the information posted on clinicaltrials.gov, this medical trial is not recruiting patients at present. This research was initially published on January 1st 2023 and last modified October 31st 2022. Despite this lack of current recruitment, there are 840 other studies seeking participants as we speak."

Answered by AI

Is this research endeavor open to participants aged 25 and over?

"This research trial is open to people aged between 18 and 65. Conversely, there are 110 trials specifically for minors and 599 studies targeting individuals over the age of 65."

Answered by AI

Who is eligible to enroll in this medical experiment?

"This clinical trial seeks 24 adults, aged between 18 and 65, who are currently suffering from anhedonia. To be eligible for the study, participants must also fulfil additional criteria: males and females of legal age; provide informed consent to participate in the research project; women of child-bearing potential must agree to use two forms of contraception while men will need to use at least one form of contraceptive measure; comply with all study requirements including psychological evaluations, cognitive assessment tests and imaging scans throughout the duration of their involvement in this medical investigation; meet DSM-5 regulations for major depressive disorder diagnosis as well as a current episode related thereto; score 6"

Answered by AI

Who else is applying?

What state do they live in?
Texas
Missouri
California
Other
How old are they?
18 - 65
What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+

What questions have other patients asked about this trial?

What is there historical rate of success? What is available after the trial, especially if the treatment seemed to have helped?
PatientReceived no prior treatments

Why did patients apply to this trial?

I have complex trauma and have had difficulty accessing my feelings in trauma therapy with a psychologist. I am dealing with anxiety and loss of focus, difficulty concentrating.
PatientReceived 2+ prior treatments
My depression has reached a level that has been unsustainable since the fall of 2020. I struggle with sleep,stress, anxiety, socialization, isolation, no longer able to stay organize. difficulty concentrating on simple task. current meds might help but not heal.
PatientReceived no prior treatments
I have had treatment resistant depression for decades that doesn’t respond to medications. I have been undergone deep TMS twice which helped but the effects didn’t last beyond a few months. I am currently undergoing in the maintenance phase of my ketamine treatment which is doing okay but I still fall pretty low sometimes and am hopeful that psilocybin might give me long term relief.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Washington University School of Medicine: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
PET Synaptogenesis After Psilocybin In DEpression Recovery
2023. "PET Synaptogenesis After Psilocybin In DEpression Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05601648.
~0 spots leftby Jan 2025
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