AuthorisedTherapeutic exploratory (Phase II)Interventional

Psilocybin in treatment-resistant depression

This research is exploring a new way to help people who have depression that hasn't improved with other common treatments. The study is investigating a substance called psilocybin. The main goal is to find out if taking psilocybin over four weeks can reduce the severity of depression symptoms, measured one week after the treatment period ends. This is a Phase II study, meaning it's still in the early stages of testing to see if the treatment works and is safe. It's an important step to understand if psilocybin could offer a new option for those struggling with long-term depression.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

LKH Graz II

Enrolment target

Start

30 Jan 2025

Treatment-resistant depression

What is this study about?

This study is about a type of depression called 'treatment-resistant depression'. This means that individuals have tried different treatments for their depression, like talking therapies or antidepressant medications, but their symptoms haven't really improved. It can be very frustrating and difficult to live with, so doctors and researchers are always looking for new ways to help.

The study is specifically looking at a substance called psilocybin. You might have heard of it because it's found in certain types of mushrooms. Researchers are carefully studying it in a medical setting to understand its effects on the brain and mood. They want to see if it could be a useful treatment for people whose depression has been difficult to manage with regular care.

The main aim is to see if, after a four-week period of taking psilocybin, participants feel less depressed one week later. This will be measured using a standard questionnaire that helps doctors understand how severe someone's depression is. This is an early-stage study, so it's about exploring whether psilocybin has a positive effect and is generally safe, rather than a final stamp of approval for treatment.

Key takeaways

New study for depression that hasn't responded to other treatments.
Investigating a substance called psilocybin.
Aims to see if depression symptoms improve after four weeks of treatment.
Open to adults aged 18 and over, both men and women.
It's a Phase II study, meaning it's an early exploration of the treatment.

Who may be eligible?

This study is looking for adults who are 18 years old or older. There is no upper age limit, meaning older adults can also take part.

Participants can be male or female. The most important thing is that they have 'treatment-resistant depression', which means their depression hasn't gotten better with standard treatments they've tried in the past.

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?
Do you have depression that hasn't improved with other treatments?
Are you able to commit to a four-week treatment period and follow-up?
Have you spoken to your doctor about your depression?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the psilocybin treatment over a period of four weeks. During and after this treatment period, you would have appointments where doctors and nurses would check your health and how you're feeling. They will use questionnaires, like the Beck Depression Inventory II, to measure any changes in your depression symptoms. The study will look at your symptoms one week after the four-week treatment ends. The total length of your involvement, including follow-up, will be explained fully by the study team.

Potential risks and benefits

Potential benefits of taking part could include an improvement in your depression symptoms, especially if other treatments haven't worked for you. However, as with any medical study, there are always potential risks; these will be fully explained to you before you decide to take part. These risks could include side effects from the medication or the experience of participating. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Austria

Common questions

What is psilocybin?

Psilocybin is a natural substance found in certain mushrooms that is being studied for its potential medical uses, including for depression.

What does 'treatment-resistant depression' mean?

It means depression that hasn't improved even after trying different common treatments like talking therapies or antidepressant medications.

Will I know if I'm getting the psilocybin or a dummy treatment?

In many studies like this, participants don't know what they're receiving. The study team will explain how this works.

How long will the study last for me?

The main treatment period is four weeks, and outcomes are checked one week afterwards. The full duration of your participation will be explained by the research team.

Where is this study taking place?

The information above doesn't say. The study team will be able to tell you the locations.