Psilocybin for Depression
(STOP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if psilocybin, a compound found in certain mushrooms, is safe and effective for individuals with spinal cord injuries (SCI) who also experience depression. Participants will receive varying doses to assess any adverse reactions, such as pain or muscle spasms, and to evaluate their overall experience. The trial will help researchers determine if psilocybin is a viable option for treating depression in individuals with SCI. It is best suited for those who have had a spinal cord injury for at least a year, also suffer from depression, and are willing to discontinue current antidepressants under supervision. As a Phase 1/Phase 2 trial, this research focuses on understanding the treatment's effects and measuring its initial effectiveness in a smaller group, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial requires participants to taper off antidepressants under clinician supervision. It does not specify about other medications, so you may need to discuss this with the study team.
Is there any evidence suggesting that psilocybin is likely to be safe for humans?
Research has shown that psilocybin, the active ingredient in "magic mushrooms," can be safe when used in controlled settings. In one study, no serious negative events occurred when participants used psilocybin for depression. Another study found that a higher dose of 25 mg was especially effective and did not cause major issues. Participants also reported feeling more empathy and having better relationships after treatment.
Overall, evidence suggests that psilocybin is generally well-tolerated. However, some individuals might experience changes in blood pressure or muscle spasms. It is important to note that this study is in an early phase, meaning researchers are still learning about the safety of psilocybin for people with spinal cord injuries (SCI). Participants in the study will help answer important questions about safety and side effects.12345Why are researchers excited about this study treatment for depression?
Researchers are excited about psilocybin for depression because it offers a novel approach compared to the typical antidepressants like SSRIs and SNRIs. Unlike these standard treatments that often take weeks to show results, psilocybin has the potential to produce rapid effects after just one or two doses. This treatment works by acting on serotonin receptors in the brain, possibly leading to significant improvements in mood and mental health. Plus, with different dosing levels being explored—low, medium, and high—there's potential to fine-tune treatment for individual needs, which is something current medications can't offer as effectively.
What evidence suggests that psilocybin might be an effective treatment for depression?
Research has shown that psilocybin may help treat depression. In one study, 75% of participants responded positively to psilocybin treatment, and 58% experienced symptom relief for up to a year. Another study found that 67% of participants remained symptom-free for at least five years. These results suggest that psilocybin can offer long-lasting relief from depression symptoms. This trial will evaluate different doses of psilocybin—high, medium, and low—to assess its effectiveness in managing depression. Although this study focuses on individuals with spinal cord injuries (SCI), the findings highlight psilocybin's potential to effectively manage depression.34678
Who Is on the Research Team?
Jill M Wecht, EdD
Principal Investigator
James J Peters VA Medical Center
Are You a Good Fit for This Trial?
This trial is for veterans with spinal cord injury (SCI) who have been injured for at least a year, are over 22 years old, weigh more than 110 lbs., can consent, and have depression. They must be off ventilators, speak English, swallow pills, allow visit recordings and share medical records. It's not specified who cannot join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive psilocybin-assisted therapy with three different doses: low (5mg), medium (10mg), and high (25mg)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including tracking adverse events and changes in depression severity
Long-term follow-up
Participants are monitored for long-term safety and effectiveness, including quality of life and wellbeing
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Trial Overview
The study tests if psilocybin is safe in SCI patients by giving three doses: low (5mg), medium (10mg), high (25mg). It checks for adverse events like pain or mood changes and how participants handle the psychedelic experience over up to seven visits within 13 months.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Psilocybin 10mg
Psilocybin 5mg
Psilocybin 25mg
Find a Clinic Near You
Who Is Running the Clinical Trial?
James J. Peters Veterans Affairs Medical Center
Lead Sponsor
Bronx Veterans Medical Research Foundation, Inc
Collaborator
Usona Institute
Collaborator
United States Department of Defense
Collaborator
Citations
1.
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 for Depression - Effective for up to a year
Participants had stable rates of response to the treatment and remission of symptoms throughout the follow-up period, with 75% response and 58% ...
Control Group Outcomes in Trials of Psilocybin, SSRIs, or ...
This meta-analysis found that participants receiving control treatment in psilocybin trials had significantly less improvement in depression ...
3.
pure.johnshopkins.edu
pure.johnshopkins.edu/en/publications/five-year-outcomes-of-psilocybin-assisted-therapy-for-major-depre/Five-year outcomes of psilocybin-assisted therapy for ...
Results: Significant and sustained reductions in depression were observed, with 67% in remission for at least five years post-treatment. Anxiety ...
Long-term outcomes of single-dose psilocybin for U.S. ...
Psilocybin can elicit sustained reductions in depression up to 12 months. ... There are some decreases in antidepressant effects between 9 and 12 ...
Control Group Outcomes: Psilocybin, SSRIs, Esketamine Trials
This meta-analysis found that participants receiving control treatment in psilocybin trials had significantly less improvement in depression ...
Psilocybin for major depressive disorder: a systematic review ...
Two of the five RCTs (40%) reported mixed results, while the other three (60%) found that psilocybin had a beneficial effect on MDD treatment.
Efficacy and safety of psilocybin in the treatment of Major ...
This meta-analysis supports psilocybin's efficacy in treating MDD, particularly at a 25 mg dose, showing a time-dependent therapeutic effect.
Psychedelics Research and Psilocybin Therapy
Previous studies by Johns Hopkins Medicine researchers showed that psychedelic treatment with psilocybin relieved major depressive disorder symptoms in adults ...
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