What is the purpose of the study?

Psilocybin is a controlled substance and a chemical compound found in some types of mushrooms. As an investigational drug, psilocybin cannot be prescribed for the treatment of depression in Canada; however, Health Canada has allowed for psilocybin to be used in this research study.

The purpose of this study is to see if psilocybin is safe, well tolerated and can improve symptoms of treatment-resistant depression. 

 

Is psilocybin safe?

Although no serious side effects for psilocybin have been reported to date, there is insufficient data to rule out the possibility of serious side effects. The numbers in brackets show how often the side-effect was reported.

 

Common (over 50%):

1) Visual and other sensory distortions, feeling of unreality & changed sense of time

2) Anxiety at the onset of the drug effects

3) Increased heart rate and blood pressure

 

Less common (about 10-40%):

1) Nausea

2) Dizziness

3) Blurred vision

4) Drowsiness

5) Sleepiness

6) Headache

7) Temporary suspiciousness

 

Rare (less than 10%):

1) Transient recurrence of disturbances in perception that are reminiscent of those experiences during one or more earlier hallucinogen intoxication. This side effect is seen rarely with recreational use of psilocybin, and has not been reported in scientific studies done under supportive clinical conditions.

2) Worsening of mental state after psilocybin experience (very rare and not seen in similar studies).

 

 

What should I know about this study?

If you have tried at least two treatments for depression for your depression and are experiencing depression, you may be eligible to participate in this study. The study team will ask you some quick questions over the phone to see if you are eligible to participate and answer any further questions you may have.

 

If you are eligible, you will receive psilocybin treatment with psychotherapy. There is a 50:50 chance you will receive psilocybin treatment without a two-week waiting period or after a two-week waiting period. The purpose of this is so that researchers can assess whether psilocybin dosing is associated with changes in depressive symptoms above and beyond changes in symptoms experienced over time when not receiving psilocybin.

 

This trial will involve a minimum of 21 study visits, including four or more psychotherapy sessions, and will last approximately 24-27 weeks, where your mood symptoms will be monitored. You will also be seen by a physician on the study team to see how you are doing.

You may be eligible to receive up to two additional doses, for a total of one-to-three psilocybin doses during the trial. You may need to complete additional study visits if you receive more than one dose of psilocybin. You will also be asked to provide vital signs and a fasting blood sample throughout the study.

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Which organization is running this study?

The Brain and Cognition Discovery Foundation (BCDF) is a registered non-profit organization with a focus on research and education in the areas of brain health and disease. Please visit  https://www.bcdfoundation.ca/ for more information about BCDF.

 

Will compensation be provided?

You will receive a modest stipend for your time. The study doctor and study staff can tell you more about this reimbursement and when you will receive it.

 

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