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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
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary study objectives
Columbia Suicide Severity Rating Scale (C-SSRS)
Electrocardiogram (ECG)
Laboratory results
+2 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
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
~530
Find a Location
Who is running the clinical trial?
Sunstone MedicalLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that affect my heart's rhythm.I have a seizure disorder.I have risk factors for a specific heart rhythm issue (like heart failure or low potassium).My recent cancer treatment has not made me too weak to function.I am 18 years old or older.I have been diagnosed with major depression for at least 3 months.I have been diagnosed with cancer.I am not pregnant, nursing, or planning to become pregnant and agree to use contraception during the study.I haven't had a stroke, heart attack, uncontrolled high blood pressure, or serious heart rhythm problems in the last year.I do not have any major health issues that could risk my safety in the study.I haven't used psychedelics in the last 6 months and not during my current depression episode.I have diabetes that is not well-controlled or requires insulin.My health tests show I might be at risk if I take psilocybin.I am not currently using antidepressants, antipsychotics, or medical cannabis.I am able to understand and agree to the study's requirements.I can complete all study tasks and attend all visits on my own.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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