Psilocybin for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effects of psilocybin, a compound found in certain mushrooms, on individuals with treatment-resistant major depressive disorder who experience anhedonia (a loss of interest or pleasure in daily activities). The trial includes two groups: one receives a 25mg dose of psilocybin, while the other receives a 1mg placebo dose, both with psychological support. Suitable candidates have major depressive disorder, have not responded well to at least two antidepressant treatments, and struggle to enjoy activities they once liked. As a Phase 2 trial, this research measures psilocybin's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.
Do I need to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop all current medications, but some medications are not allowed. You need to stop using drugs or supplements that interfere with the study, like certain antidepressants and serotonergic supplements, for 5 half-lives before the baseline visit. SSRIs and SNRIs may be allowed at the PI's discretion. Benzodiazepines and non-benzodiazepine sleeping meds can continue if stable for 6 weeks before screening. Psychostimulants must be stopped for 5 half-lives before the baseline visit.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you must stop all current medications, but certain drugs like antipsychotics, trazodone, and others must be stopped for a period before the trial. Some medications, like SSRIs, may be allowed at the discretion of the investigator.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that psilocybin, a substance found in certain mushrooms, has been studied for its safety in treating depression. In past studies, most participants tolerated psilocybin well. Some experienced mild side effects, such as nausea or headaches, but serious side effects were rare. It is important to remember that psilocybin is still under investigation, and its safety is not yet fully understood. However, its testing in a Phase 2 trial indicates that earlier studies found it safe enough to proceed. Always consult a healthcare provider before joining a trial.12345
Why do researchers think this study treatment might be promising for depression?
Most treatments for depression, like SSRIs and SNRIs, work by altering serotonin levels over several weeks. But psilocybin, a psychedelic compound found in certain mushrooms, acts differently. It targets serotonin receptors in the brain more directly and can lead to rapid mood improvements. Researchers are excited because psilocybin has the potential to produce significant antidepressant effects in just a day or two, offering a faster-acting alternative to traditional medications.
What evidence suggests that psilocybin might be an effective treatment for depression?
Research has shown that psilocybin can help treat depression, even when other treatments have failed. In this trial, participants will receive either a 25 mg dose of psilocybin or a 1 mg active placebo. One study found that a single 25 mg dose of psilocybin reduced depression symptoms, while smaller doses did not. Another study showed that the positive effects of a 25 mg dose could last up to a year. Several studies consistently found that psilocybin reduces depression symptoms with few side effects. These findings suggest that psilocybin might help improve symptoms like losing interest or pleasure in activities for people with major depression.678910
Who Is on the Research Team?
Andrew M Novick, MD PhD
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
This trial is for individuals who have major depressive disorder that hasn't improved with standard treatments. Participants should be experiencing anhedonia, which is the inability to feel pleasure.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Psilocybin 1mg or 25mg capsule orally, administered with psychological support, on dosing day
Follow-up
Participants are monitored for changes in depression and anhedonia scores post-dosing
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Psilocybin is already approved in United States, European Union for the following indications:
- Treatment-resistant depression (TRD) under Breakthrough Therapy designation
- Treatment-resistant depression (TRD) under PRIME designation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor