Efficacy of psilocybin and trazodone combination in treatment-resistant depression: a randomized controlled proof-of-concept study (PSILOTRAZ)
This research study, called PSILOTRAZ, is investigating a new treatment for depression that hasn't gotten better with standard therapies. It's looking at whether a single dose of psilocybin, a substance found in some mushrooms, when combined with a medication called trazodone, can help people feel less depressed. The study is comparing this combination to other options, including placebos (dummy pills). Researchers will measure changes in mood and depression symptoms over time to see how well the new treatment works. This is an early-stage study to see if the idea has promise for future, larger trials.
At a glance
What is this study about?
This study is called PSILOTRAZ, and it's looking into new ways to help people who have depression that hasn't improved with typical treatments. This type of depression is often called 'treatment-resistant depression'. The main goal is to find out if a specific combination of medicines can make a difference for these individuals.
The study focuses on giving a single dose of two different medicines together: psilocybin and trazodone. Psilocybin is a substance found in certain mushrooms that can affect your mind, and trazodone is a medication often used for depression. Researchers want to see if taking them together leads to better results than taking trazodone alone, or other combinations with placebos (dummy pills that look like the real medicine but contain no active ingredients).
To see how well the treatment works, the research team will use a standard tool called the Montgomery-Åsberg Depression Rating Scale (MADRS) to measure changes in depression symptoms over time. They will compare scores before the treatment and one month afterwards. They'll also look at other things like overall well-being, how quickly people respond to treatment, and if anyone goes into remission (meaning their depression symptoms become very low). This is a 'Phase II' study, which means it's an early step to explore if this treatment idea is safe and shows enough promise to be studied further.
Key takeaways
- This study explores a new treatment for depression that hasn't responded to other therapies.
- It tests a single dose of psilocybin combined with trazodone.
- Researchers will compare this combination to placebos and other options.
- Participation involves taking medication and having follow-up appointments over several months.
- The study aims to see if this treatment can reduce depression symptoms and improve well-being.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or older. The study is open to both men and women.
Since this study is specifically for treatment-resistant depression, participants must have a diagnosis of depression that hasn't responded well to other treatments you've tried in the past. The research team will check all your medical information to make sure you fit the study's specific health requirements.
Important: The study team will need to review your full medical history, current medications, and overall health to confirm if this study is right for you. They will explain everything clearly before you make any decisions.
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.
- Are you 18 years old or older?
- Have you been diagnosed with depression?
- Has your depression not improved with other treatments?
- Are you comfortable potentially receiving a placebo (dummy pill)?
What does participation involve?
If you decide to take part in this study, you'll be assigned to one of four groups, and you won't know which group you're in. One group will receive psilocybin and trazodone, another will get a placebo (dummy pill) and trazodone, and there will be other combinations, including placebos alone. You will receive a single dose of the study medication or placebo on one day.
Over the course of the study, you'll have several visits or assessments. These will include check-ups, answering questionnaires about your mood and feelings (like the MADRS and BDI), and potentially blood tests to monitor your health. These visits will happen at different times, from shortly after taking the study medication up to three months later. The team will carefully monitor you for any side effects throughout this period. The overall duration you'll be involved in the study will be a few months, with regular check-ins.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
What exactly is 'treatment-resistant depression'?
This means your depression hasn't gotten better even after trying other types of treatments, such as different antidepressant medications or talking therapies.
What is psilocybin?
Psilocybin is a natural substance found in certain types of mushrooms that can affect your brain and how you see and feel things. In this study, it's given in a carefully controlled way as a capsule.
What is trazodone?
Trazodone is a medication often used to treat depression. In this study, it's given as drops.
Will I know if I'm getting the real medication or a dummy pill?
No, this is a 'blinded' study, meaning neither you nor the study team will know which treatment you are receiving until the study is over. This helps ensure fair and accurate results.
How long will I be involved in the study?
You will be followed for a few months after receiving the study medication, with regular check-ups to see how you are doing.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.