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Psychedelic
Psilocybin for Depression
Phase 2
Waitlist Available
Research Sponsored by Maryland Oncology Hematology, PA
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 is exploring whether a 25mg dose of psilocybin is safe and effective in treating cancer patients with depression.
Eligible Conditions
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
5 Dimension Altered State of Consciousness (5D-ASC)
Caregiver Oncology Quality of Life Questionnaire (CarGOQol)
Changes in electrocardiographs.
+13 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%
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%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Fungal infection
2%
Vomiting
2%
Musculoskeletal pain
2%
Rhinorrhea
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
1Treatment groups
Experimental Treatment
Group I: Psilocybin 25mgExperimental Treatment1 Intervention
Psilocybin 25mg Single does with supportive conditions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Maryland Oncology Hematology, PALead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your depression score is 18 or higher during the screening and baseline assessments.Your personal circumstances or behavior make it difficult to build a trusting relationship or safely use psilocybin.You are currently receiving or have recently received chemotherapy or radiation therapy that affects your overall physical ability.You have signed the informed consent form.You have used drugs like psilocybin (magic mushrooms) or other psychedelics, except for medical marijuana, within the last year. Additionally, you have used psychedelics during your current episode of depression.You are able to understand and agree to participate in the study, as determined by the investigator.You must be 18 years or older during the first screening of the trial.Your depression level is high, as measured by the HAM D 17 score, during screening and baseline visits.You will be excluded if you have a history of certain psychiatric conditions.You have had thoughts of suicide or have engaged in suicidal behaviors within the past year, or a doctor has determined that you are at high risk for suicide based on your interview with them.You are not taking antidepressant, antipsychotic medications or medical cannabis during the screening process.You have a condition that causes seizures.You have been diagnosed with cancer as classified by ICD-10 codes C00 to C97.You have been diagnosed with major depression and it has been documented by a doctor or mental health professional.Your diabetes is not well controlled or you need to take insulin to manage it.You have been diagnosed with certain mental health conditions like schizophrenia, bipolar disorder, or borderline personality disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin 25mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Depression Patient Testimony for trial: Trial Name: NCT04593563 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many study participants are part of this research project?
"Presently, this study is not admitting new patients. The clinical trial was first announced on September 1st, 2020 and has had one update since then on October 14th, 2021. For individuals looking for other studies, there are 2117 trials for major depressive disorder (mdd) and 37 psilocybin studies Currently enrolling participants."
Answered by AI
Has the FDA cleared psilocybin for therapeutic use?
"While there is some evidence suggesting that Psilocybin is safe, it only received a score of 2 because there is no data currently supporting its efficacy."
Answered by AI
Are there any other ongoing trials that involve Psilocybin?
"Psilocybin is being studied in 37 different clinical trials, with the majority of research based out of Vancouver, Washington. 0 of these studies are currently in Phase 3. Psilocybin clinical trials can be found at 40 locations across the globe."
Answered by AI
Are people with the required medical conditions still able to sign up for this research project?
"Unfortunately, this research is no longer recruiting patients. Although, according to the latest update on October 14th 2021, if you are seeking other studies there are 2117 trials actively admitting participants with major depressive disorder (mdd) and 37 studies for Psilocybin actively recruiting participants."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Pennsylvania
Maryland
Other
How old are they?
65+
18 - 65
What site did they apply to?
Maryland Oncology Hematology PA
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
I have stage 4 ovarian cancer and only have months to live. I have suffered from depression for decades.
PatientReceived 2+ prior treatments
Have tried many other forms of treatment and therapy (medication, EMDR, alternative medication, therapy, etc).
PatientReceived no prior treatments
I have suffered with severe depressuon/anxiety for over thirty years. I have tried many prescribed anti-depressiin drugs, herbal remedies, accupuncture, energy work, EMDR and brain spotting. Hoping to find some help with this study. Thank you so much- Anne.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do screening visits take? How does compensation work?
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Phone Call
Most responsive sites:
- Maryland Oncology Hematology PA: < 24 hours
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