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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
Must not have
The subject has a history of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation
The subject must refrain from starting any new medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every week until week 14.
Summary
This trial tests if very small doses of psilocybin can safely and effectively improve mood in people with major depression who don't respond to or don't want standard treatments. Psilocybin may help by affecting brain chemicals related to mood. Psilocybin has shown promise as a treatment for major depressive disorder and was designated as a breakthrough therapy by the FDA in 2019.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a stroke, mini-stroke, brain aneurysm, or a blood vessel malformation.
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I will not start any new medications during the trial.
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I have diabetes that requires insulin and I haven't had low blood sugar with oral medications.
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I am currently taking daily medication for mental health or pain.
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I do not have an ongoing major depressive episode.
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I have epilepsy and a history of seizures.
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I am currently taking medication such as ergot alkaloids or simvastatin.
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I do not have severe kidney, liver disease, or serious brain conditions.
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I am pregnant, nursing, or not using effective birth control.
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I am not currently using any strong medication that affects how drugs are processed in my body.
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I will not start any new health practices like diet changes or meditation.
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I have heart or blood vessel conditions but no recent severe symptoms.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression often target the serotonin system to improve mood and neuroplasticity. Psilocybin, for example, interacts with serotonin receptors, particularly 5-HT2A, which may enhance mood and promote neuroplasticity.
Similarly, Selective Serotonin Reuptake Inhibitors (SSRIs) increase serotonin levels in the brain by inhibiting its reuptake, thereby improving mood. Tricyclic Antidepressants (TCAs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) also increase serotonin and norepinephrine levels, which can alleviate depressive symptoms.
Understanding these mechanisms is crucial for depression patients as it helps in selecting the most effective treatment tailored to their specific neurochemical needs.
Modulation of Serum Brain-Derived Neurotrophic Factor by a Single Dose of Ayahuasca: Observation From a Randomized Controlled Trial.
Modulation of Serum Brain-Derived Neurotrophic Factor by a Single Dose of Ayahuasca: Observation From a Randomized Controlled Trial.
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.
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