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Hallucinogen

Psilocybin for Depression in Adults with Cancer

Phase 2
Recruiting
Research Sponsored by Sunstone Medical
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 8 weeks
Awards & highlights

Study Summary

This trial will explore if psilocybin can help people with both MDD & cancer. Those with no prior experience to psilocybin & cancer can take part.

Who is the study for?
Adults with both Major Depressive Disorder (MDD) and cancer, who are not on antidepressants or antipsychotics, can join this trial. They must have a depression score of ≥20 and be able to consent. Pregnant women, those with recent drug abuse or certain medical conditions like heart issues or uncontrolled diabetes cannot participate.Check my eligibility
What is being tested?
The study tests if two doses of psilocybin (25 mg each) help adults with MDD and cancer feel better compared to a placebo. The first dose is given in a controlled setting; patients who don't improve may receive another dose openly later.See study design
What are the potential side effects?
Psilocybin could cause headaches, nausea, dizziness, changes in perception or mood swings during the treatment sessions. Long-term side effects are still being studied but might include similar symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary outcome measures
Columbia Suicide Severity Rating Scale (C-SSRS)
Electrocardiogram (ECG)
Laboratory results
+2 more

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%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PsilocybinExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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?

Sunstone MedicalLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Psilocybin (Hallucinogen) Clinical Trial Eligibility Overview. Trial Name: NCT05947383 — Phase 2
Cancer Research Study Groups: Psilocybin, Placebo
Cancer Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05947383 — Phase 2
Psilocybin (Hallucinogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05947383 — Phase 2

Frequently Asked Questions

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

What is the uppermost limit for enrollment in this investigation?

"Affirmative, the information posted on clinicaltrials.gov attests to this medical trial actively searching for individuals. The experiment was first made public on July 7th 2023 and has since been edited in the same month - with 56 participants needed at one site."

Answered by AI

Has the US Food and Drug Administration sanctioned Psilocybin for clinical use?

"There is some evidence for the safety of psilocybin, so its risk rating was assigned a score of 2. However, this Phase 2 trial does not have any data that supports efficacy."

Answered by AI

Are there any opportunities to enroll in this clinical trial currently available?

"That is correct. Clinicaltrials.gov shows that this medical study, which was first made public on July 7th 2023, is currently recruiting patients from one location with the goal of enrolling 56 participants total."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Sunstone Medical, PC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Sunstone Medical, PC: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer
2023. "A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of up to Two Doses of Psilocybin for the Treatment of Major Depressive Disorder in Adults With Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05947383.
All > Mdd > Psilocybin
~36 spots leftby Aug 2025
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