Psilocybin-assisted CBT for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how combining psilocybin, a substance found in magic mushrooms, with therapy might help people with depression. Researchers aim to determine if this combination enhances therapy effectiveness and if participants find it acceptable and feasible. Participants will either engage in a detailed therapy program or receive less intensive support, but both groups will participate in psilocybin sessions. This trial is suitable for those experiencing ongoing depression and who have a support person to assist them after sessions.
As a Phase 1 and Phase 2 trial, this research focuses on understanding how the treatment works and measuring its effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
Yes, you must stop taking antidepressants or other medications that affect serotonin, like St. John's Wort, to participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that psilocybin has been studied for safety in various trials. One study focused on its use for major depressive disorder (MDD) and found that a 25 mg dose of psilocybin was effective and generally well-tolerated. Another review found that psilocybin not only helps reduce depression but also lowers anxiety in people with MDD.
Another trial examined psilocybin's safety and reported that a single dose was generally safe for participants. Some mild to moderate side effects, such as headaches and nausea, were noted, but these usually didn't last long.
Based on these findings, psilocybin appears generally safe for humans, especially in controlled settings like clinical trials. However, discussing any concerns with the study team before joining a trial is important.12345Why are researchers excited about this trial's treatments?
Psilocybin-assisted CBT for depression is unique because it combines a psychedelic substance, psilocybin, with cognitive-behavioral therapy (CBT) to potentially enhance therapeutic outcomes. Unlike standard antidepressants that often take weeks to work, psilocybin may offer rapid symptom relief, possibly within just a few sessions. Researchers are excited about psilocybin's novel mechanism, as it targets serotonin receptors in the brain, potentially fostering new neural connections and personal insights during therapy. Additionally, this approach could offer a more holistic treatment by addressing both the psychological and neurochemical aspects of depression.
What evidence suggests that this trial's treatments could be effective for depression?
Research has shown that psilocybin can significantly alleviate depression symptoms. In many studies, more than half of the participants with major depression experienced improvement and reduced anxiety after taking psilocybin. In this trial, one group will receive Psilocybin-assisted cognitive-behavioral therapy (CBT), while another group will receive Psilocybin with minimal supportive therapy. A 25 mg dose has proven effective, with benefits that can increase over time. Taking two doses can rapidly reduce depression symptoms. Participants also report feeling more understanding and accepting of themselves after treatment, with no serious side effects.12678
Are You a Good Fit for This Trial?
This trial is for individuals with major depressive disorder. Participants will receive two doses of psilocybin and undergo therapy sessions. They must be suitable for the study based on specific criteria set by the researchers, which are not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two doses of psilocybin (10mg and 25mg) along with either 12 sessions of CBT or 6 sessions of supportive therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Trial Overview
The trial tests a combination of psilocybin-assisted therapy with cognitive-behavioral therapy (CBT) against standard psilocybin-assisted therapy to see if it's feasible and beneficial for treating depression.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive 12 sessions of cognitive-behavioral therapy (CBT) along with two psilocybin-drug sessions -- the first following the third CBT session (10mg of psilocybin, taken orally) and the second following the sixth CBT session (25mg of psilocybin, taken orally).
Participants will receive 6 sessions of supportive, non-directive therapy along with two psilocybin-drug sessions -- the first following the third therapy session (10mg of psilocybin, taken orally) and the second following the fourth therapy session (25mg of psilocybin, taken orally).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Citations
Psilocybin for major depressive disorder: a systematic review ...
Psilocybin was effective in improving depressive symptoms in over half of the included studies and reduced anxiety symptoms in patients with MDD.
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.
Five-year outcomes of psilocybin-assisted therapy for ...
Participants reported enhanced empathy, self-acceptance, and improved interpersonal relationships. No severe adverse events were reported.
Single-dose psilocybin-assisted therapy in major ...
Psilocybin has been suggested as a novel, rapid-acting treatment for depression. Two consecutive doses have been shown to markedly decrease symptom severity.
a living systematic review, meta-analysis, and data resource
As described below, our initial synthesis of these data suggests that psilocybin shows a significant reduction in depression symptoms compared ...
6.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06308653?term=psilocybin&aggFilters=status:rec%20act&viewType=Table&rank=5NCT06308653 | Psilocybin for Major Depressive Disorder ...
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Psilocybin 25 mg versus placebo in adults with MDD, as assessed by the ...
Single-Dose Psilocybin Treatment for Major Depressive ...
This randomized clinical trial examines the timing of onset of action, durability of benefit, and safety profile of single-dose psilocybin ...
Single-Dose Psilocybin for a Treatment-Resistant Episode ...
Psilocybin is being studied for use in treatment-resistant depression.In this phase 2 double-blind trial, we randomly assigned adults with ...
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