Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression
If you have severe depression that hasn't improved with other treatments, this study might be for you. Researchers are exploring a new approach using psilocybin, which is a substance found in 'magic mushrooms'. Previous studies have shown that psilocybin, when given with professional support, can help people with depression feel better for longer periods. This particular study wants to understand the role of having a 'monitor' – someone who is with you during the psilocybin therapy sessions. They want to see if having this support person changes how well the treatment works for adults aged 18 to 70.
At a glance
What is this study about?
This study is exploring a new way to help people who have 'treatment-resistant depression'. This is a type of severe depression that hasn't gotten better even after trying at least two different antidepressant medications. It can be very frustrating and difficult to live with, and researchers are constantly looking for new and effective ways to help.
Here, they are looking at psilocybin, a natural substance found in 'magic mushrooms'. Don't worry, it's given in a carefully controlled medical setting with professional help. Previous research has suggested that psilocybin, when combined with talking therapy and support, might have a strong and lasting positive effect on depression. This is exciting because it could offer hope to those who haven't found relief from traditional treatments.
The main aim of this study is to understand the role of a 'psilocybin monitor'. This is a person who would be with you during your psilocybin therapy sessions. The researchers want to find out if having this monitor present makes a difference to how effective the psilocybin treatment is, and how you experience it.
Key takeaways
- This study is for adults with severe depression resistant to other treatments.
- It uses psilocybin, a substance from 'magic mushrooms', given with support.
- The main focus is to see how a 'monitor' during therapy affects the results.
- Participants need to be 18-70 years old and meet specific health criteria.
- Any current antidepressants or certain other medications must be safely stopped beforehand.
Who may be eligible?
This study is looking for adults between 18 and 70 years old who are currently living with severe depression that hasn't improved after trying at least two different antidepressant medications. You'll need to be an outpatient, meaning you're not staying in a hospital, and be able to understand and agree to take part.
It's important that you can read and understand English well enough to go through the study forms and questionnaires. You'll also need to be able to take medication by mouth. If you are a woman who could become pregnant, or a man who could get someone pregnant, you will need to use effective birth control during the study.
Before taking part, you'll need to gradually stop any current antidepressants, along with certain other medications like antipsychotics or mood stabilisers, under medical supervision. The study staff will check your health carefully, including blood tests, to make sure it's safe for you to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I aged between 18 and 70 years old?
- Do I have depression that hasn't improved after trying at least two different antidepressant medications?
- Am I an outpatient (not currently staying in a hospital)?
- Can I understand and speak English well enough for the study forms?
- Am I willing and able to safely stop my current antidepressants (if applicable) under medical guidance?
- Will I use effective contraception if I could become pregnant or make someone pregnant?
What does participation involve?
The study involves taking psilocybin, which would be given as an oral medication. You would also receive psychological support during your treatment. The study is specifically looking at the role of a 'psilocybin monitor', so some participants might have a monitor present during their sessions, while others might not, or they might be looking at different types of monitoring. You would have several visits for assessments, discussions, and to receive the treatment. It's not mentioned how long the entire study would last, but typically these kinds of trials involve an initial screening, treatment sessions, and then follow-up appointments over several weeks or months to see how you are doing.
Potential risks and benefits
Locations (2)
- Toronto Western Hospital (University Health Network)Verified postcodeToronto, Canada
- Centre for Addiction and Mental HealthVerified postcodeToronto, Canada
Common questions
What is psilocybin therapy?
It's a treatment where a natural substance from 'magic mushrooms' (psilocybin) is given in a medical setting, combined with talking therapy and support.
What does 'treatment-resistant depression' mean?
It means your depression hasn't gotten better even after trying at least two different antidepressant medications.
What is a 'psilocybin monitor'?
It's a person who will be with you during your psilocybin therapy sessions. The study wants to see how having this support person affects the treatment.
Do I have to stop my current antidepressants?
Yes, if eligible, you would need to gradually stop your current antidepressants and some other medications under medical supervision before starting the study.
Will 'magic mushrooms' be given to me?
No, you will be given a carefully measured dose of psilocybin, which is the active chemical found in 'magic mushrooms', in a controlled medical environment, not the mushrooms themselves.
How to find out more
Emily Gilbert
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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