Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Effect of psilocybin on the positive valence system in treatment-resistant depression: a pilot clinical neuroimaging study

This study is exploring how psilocybin, a naturally occurring substance, might help people who have depression that hasn't improved with standard treatments. It's a pilot study, meaning it's an early look into a new approach. The main goal is to use special brain scans (fMRI) to observe how psilocybin affects specific areas of the brain involved in how we feel pleasure and motivation, both before and after treatment. Researchers will also be checking changes in people's depression symptoms using questionnaires over several months, and asking about their experience with the treatment, including any side effects. This research aims to understand if psilocybin could offer a new way to help those struggling with severe depression.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Nimes

Enrolment target

Start

26 Sep 2024

depression mental disorders

What is this study about?

This study is looking into a treatment called psilocybin for people who have depression that has been very difficult to treat with usual methods. Think of it like this: sometimes, when someone is very depressed, their brain might not respond well to things that normally bring joy or motivation. This study wants to see if psilocybin can help 'reset' or change how certain parts of the brain work, especially those linked to our feelings of reward and effort.

The researchers will use a special type of brain scan called an fMRI. This scan lets them look at brain activity in specific areas before and after someone receives the psilocybin treatment. They are particularly interested in parts of the brain that play a role in how we assess effort and feel positive emotions. By doing this, they hope to understand the actual changes happening in the brain.

Besides brain scans, the study will also track how participants feel by using questionnaires about their mood and depression symptoms. They'll do this at several points: right at the start, a few days after treatment, and then again after one month and three months. This helps them see if the psilocybin treatment leads to improvements in how people feel generally and in their daily activities. They will also ask patients about their experience with the treatment sessions and any side effects.

Key takeaways

This study explores psilocybin for severe, treatment-resistant depression.
It uses brain scans (fMRI) to see how psilocybin affects brain activity.
Researchers will also track changes in depression symptoms and mood.
It's a pilot study, meaning it's an early investigation into a new treatment approach.
The study lasts about three months with follow-up appointments.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you must have depression that has not responded well to other treatments. This means you've likely tried different approaches for your depression without much success.

Because this is a specific type of study involving brain scans and a substance like psilocybin, there will be other health checks and criteria to ensure it's safe for you to take part. The study team will discuss all of these with you in detail.

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 available for brain scans and follow-up visits over three months?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would first have an initial visit where your eligibility is checked, and you would have your first brain scan (fMRI). You would then receive the psilocybin treatment, which would be given in a supervised setting. Following the treatment, you would have another fMRI brain scan. Over the next three months, you would have follow-up evaluations, involving questionnaires about your mood and experiences, at four days, one month, and three months after your treatment. You would also be asked about your satisfaction with the treatment sessions and any side effects you might experience. The total duration of your active involvement in the study would be approximately three months, starting from your first visit.

Potential risks and benefits

Taking part in this study could potentially offer some benefits if psilocybin proves to help with treatment-resistant depression. However, it's important to remember this is a pilot study, meaning it's an early investigation, and the benefits are not guaranteed. As with any medical treatment or research, there are also potential risks; you might experience side effects from the psilocybin, which will be carefully monitored. The study team will explain all known side effects. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is psilocybin?

Psilocybin is a natural compound found in certain types of mushrooms that is being studied for its potential effects on the brain.

What is 'treatment-resistant depression'?

This means your depression hasn't gotten better even after trying standard treatments like different medications or therapies.

What is an fMRI scan?

An fMRI is a special type of brain scan that can show which parts of your brain are active. It's safe and doesn't use radiation.

Will I know if the psilocybin is helping?

The study will track your mood and symptoms using questionnaires over several months to see if there are any improvements.

Is this a new treatment for depression?

Psilocybin is currently being researched, and this study is an early step to understand its potential effects. It's not a standard approved treatment yet.