Psilocybin-Assisted Therapy for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests psilocybin, a compound in certain mushrooms, to determine its effectiveness in quickly treating depression. Researchers aim to understand how psilocybin alters brain activity and mental flexibility in individuals with depressive symptoms. Participants must have a depression diagnosis with noticeable symptoms and be able to bring a support person on dosing days. The goal is to discover a treatment that works faster and lasts longer than current antidepressants. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in depression treatment.
Is there any evidence suggesting that psilocybin is likely to be safe for humans?
Research has shown that psilocybin, the main ingredient in this treatment, can cause some side effects. Studies found that a 25 mg dose of psilocybin was linked to negative experiences, particularly immediately after ingestion. Some participants reported increased thoughts about suicide during this period.
It is important to note that psilocybin is still under investigation for its safety. This study is part of a phase 2 trial, meaning researchers are still assessing its safety and effectiveness. Phase 2 trials often focus on how well participants tolerate a treatment and help identify common side effects. While psilocybin shows promise for treating depression, researchers continue to gather information about its safety in humans.12345Why do researchers think this study treatment might be promising for depression?
Unlike the standard antidepressants that typically target neurotransmitters like serotonin or norepinephrine, psilocybin, a compound found in certain mushrooms, works uniquely by affecting serotonin receptors in the brain in a different way. This novel action may lead to rapid improvements in mood and outlook, potentially with just a single or few doses, compared to the daily regimen required by traditional antidepressants. Researchers are excited because psilocybin could transform the treatment landscape for depression, offering faster relief with potentially fewer side effects.
What evidence suggests that psilocybin might be an effective treatment for depression?
Research has shown that psilocybin, a substance found in certain mushrooms, can help reduce depression symptoms. In several studies, participants who took psilocybin experienced significant improvements in their depression, with effects lasting up to a year. For instance, one study found that a 25 mg dose led to a noticeable decrease in depression within three weeks. Another study demonstrated that psilocybin had a quick and long-lasting effect on major depressive disorder. While more research is needed, these findings suggest psilocybin could be a promising treatment option for those dealing with depression. Participants in this trial will receive a 25 mg open-label dose of synthetic psilocybin to further evaluate its effectiveness.12678
Are You a Good Fit for This Trial?
This trial is for adults over 18 diagnosed with depression, who have a support person to accompany them after dosing. Women of childbearing age must use two forms of birth control and test negative for pregnancy before treatment.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive psilocybin-assisted therapy, including MRI scanning and biomarker assessments
Follow-up
Participants are monitored for acute effects of psilocybin on depression and psychological flexibility
Extended Follow-up
Participants are monitored for persisting effects of psilocybin on depression and psychological flexibility
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Trial Overview
The study tests psilocybin-assisted therapy as a treatment for depression. Participants receive psilocybin and undergo brain scans and other biological assessments to see how the drug affects brain activity and mood.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Citations
Psilocybin, an Effective Treatment for Major Depressive ... - PMC
It was found that every study significantly favoured the use of psilocybin in reducing depressive symptoms, with few side effects.
Short-Term and Late-Term Effects of Psilocybin on ...
These results suggest that psilocybin may provide a rapid and relatively long-lasting antidepressant effect on major depressive disorder, ...
3.
hopkinsmedicine.org
hopkinsmedicine.org/news/newsroom/news-releases/2022/02/psilocybin-treatment-for-major-depression-effective-for-up-to-a-year-for-most-patients-study-showsPsilocybin Treatment for Major Depression Effective for Up ...
The researchers reported that psilocybin treatment in both groups produced large decreases in depression, and that depression severity remained ...
Long-term outcomes of single-dose psilocybin for U.S. ...
This paper presents 12-month results from an open-label pilot study assessing the effects of 25 mg psilocybin in Veterans with severe TRD.
Efficacy and Safety of Psilocybin in Treatment-Resistant ...
Importance: Psilocybin shows promise in treating depression, although limitations of previous research warrant further research. Objective: To ...
Efficacy and Safety of Psilocybin in Treatment-Resistant Major ...
Psilocybin, 25 mg, was linked to adverse events, predominantly acutely, and was associated with higher reports of suicidal ideation on dosing ...
Single-Dose Psilocybin for a Treatment-Resistant Episode ...
In this phase 2 trial involving participants with treatment-resistant depression, psilocybin at a single dose of 25 mg, but not 10 mg, reduced ...
Psychedelics Research and Psilocybin Therapy
2022 (Milestone) : Psilocybin Treatment for Major Depression May be Effective for Up to a Year. Previous studies by Johns Hopkins Medicine researchers showed ...
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