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Psychedelic
Psilocybin Microdosing for Depression
Phase 2
Recruiting
Research Sponsored by Rotem Petranker
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a preexisting diagnosis of PDD with dysthymic subtype or receive a diagnosis of PDD with dysthymic subtype during screening.
Participants must be 18 to 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every week until week 14.
Awards & highlights
Study Summary
This trial is testing whether small doses of psilocybin, a compound found in some mushrooms, can help people with Persistent Depressive Disorder.
Who is the study for?
Adults aged 18-65 with Major Depressive Disorder can join this trial. They must speak and read English well, have a high school education, not use psychoactive drugs or alcohol before sessions, and women must test negative for pregnancy and use birth control. Excluded are those with certain medical conditions like uncontrolled blood pressure, seizures, cancer history; those on specific medications; smokers; substance abuse disorders within the last 5 years; unstable health conditions.Check my eligibility
What is being tested?
The trial is testing if small doses of psilocybin (2mg) can safely improve mood in people with depression without causing hallucinations. Participants will receive either psilocybin or a placebo first to compare effects.See study design
What are the potential side effects?
Possible side effects may include mild headaches, nausea, dizziness or changes in mood or perception shortly after taking the drug. Since it's microdosing, typical psychedelic experiences like visual changes are unlikely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with persistent depressive disorder, dysthymic subtype.
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I am between 18 and 65 years old.
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I am between 18 and 65 years old.
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I have been diagnosed with major depression, including long-term depression.
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I agree not to take any over-the-counter drugs or supplements without approval.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every week until week 14.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every week until week 14.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Patient Health Questionnaire Somatic-Anxiety-Depression
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open LabelExperimental Treatment2 Interventions
In this condition participants will receive psilocybin once weekly for 4 weeks, and will be told that they are receiving psilocybin.
Group II: Blinded PsilocybinExperimental Treatment1 Intervention
In this condition participants will receive psilocybin once weekly for 4 weeks, but they will not know whether they receive placebo or psilocybin.
Group III: Blinded PlaceboPlacebo Group1 Intervention
In this condition participants will receive an inert placebo once weekly for 4 weeks, but they will not know whether they receive placebo or psilocybin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo first
2008
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Rotem PetrankerLead Sponsor
Nikean FoundationUNKNOWN
1 Previous Clinical Trials
15 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have given informed consent.I have had a stroke, mini-stroke, brain aneurysm, or a blood vessel malformation.I have been diagnosed with persistent depressive disorder, dysthymic subtype.I will not start any new medications during the trial.I have diabetes that requires insulin and I haven't had low blood sugar with oral medications.None of my close family has schizophrenia, bipolar disorder, or a psychotic disorder.You should not have certain mental health conditions like Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, or other conditions that may make it difficult to establish trust or safely use psilocybin.I am currently taking daily medication for mental health or pain.I am between 18 and 65 years old.I am between 18 and 65 years old.You have not used any drugs that alter your mind or perception in the past 6 months.I do not have an ongoing major depressive episode.I can fluently speak and read the main language used at the study site.I have epilepsy and a history of seizures.I have a history of cancer.You cannot be someone who smokes regularly.I have used steroids in the last two weeks.I am currently taking medication such as ergot alkaloids or simvastatin.I agree not to use any psychoactive substances or alcohol 24 hours before each psilocybin dose.You have had a serious head injury or trauma in the past, as determined by the doctor.I do not have severe kidney, liver disease, or serious brain conditions.I am pregnant, nursing, or not using effective birth control.I am not currently using any strong medication that affects how drugs are processed in my body.I will not start any new health practices like diet changes or meditation.I have been diagnosed with major depression, including long-term depression.I agree not to take any over-the-counter drugs or supplements without approval.I have heart or blood vessel conditions but no recent severe symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Blinded Placebo
- Group 2: Blinded Psilocybin
- Group 3: Open Label
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently being sought for this experiment?
"No, this particular clinical trial is not recruiting patients at the moment. However, it was last updated on March 8th, 2022 and initially posted April 1st, 2022. There are 857 other ongoing trials that are actively searching for participants."
Answered by AI
Would it be possible for me to take part in this research?
"Eligible patients for this study should have been diagnosed with dysthymic disorder and be between 18-65 years old. Currently, the research team is looking to enroll 50 individuals."
Answered by AI
Does this trial have any age restrictions?
"The age limit for this particular study is 18-65. Out of the 722 total clinical trials, 112 are designed for patients who have not yet reached adulthood while 610 are intended for an older demographic."
Answered by AI
What was the process for Psilocybin to get FDA approval?
"Psilocybin's safety is estimated to be a 2. This is due to the fact that this medication is still in Phase 2 clinical trials, meaning while there are studies supporting its safety, there is not yet any data backing its efficacy."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
New Jersey
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
Psych Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I am 72 year’s and have had depression since I was around 15 year’s old. I have tried every medication available since my mid-30’s. Some worked for various periods of time but eventually they all lost their effect. I have tried ECT and Esketamine treatment but they were not helpful.
PatientReceived 2+ prior treatments
I have been on antidepressants for many years with some improvement. In 2020 I experienced a traumatic event (compounding developmental trauma and a history of intimate partner violence for 29 years). Psychotherapy and EMDR had been helpful in the past but this time there was no appreciable improvement of symptoms. Medication has been adjusted with only partial improvement. I am a 23 year member of a 12 step program, and while that helps to maintain, symptoms persist and are cyclically overwhelming. Family doctor suggested I look for a clinical trial of Psilocybin.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long do the screenings take? Does my age work against me?
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Psych Research: < 48 hours
Typically responds via
Email
Average response time
- < 2 Days
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