AuthorisedTherapeutic exploratory (Phase II)Interventional

Antidepressant effects of psilocybin in the absence of serotoninergic psychedelic experience: a dimensional functional neuroimaging approach

This research is investigating a new drug called pimavanserin for people experiencing major depression. Scientists want to understand if this medication can reduce symptoms of depression by affecting how different parts of the brain communicate with each other. This is particularly interesting because pimavanserin is thought to work without causing the 'psychedelic' experiences that some other similar treatments might. The study will use special brain scans, like MRI, to observe these changes in brain activity. The goal is to see if any changes in brain connections after taking the drug are linked to improvements in mood. This is an early-stage study, meaning it's exploring whether the treatment works and how.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Enrolment target

Start

04 May 2026

Major depressive disorder

What is this study about?

This study is exploring a new type of treatment for major depression. It's called pimavanserin, and it's being tested to see if it can help people who are struggling with their mood.

The main idea behind this research is to see if pimavanserin can improve depression by changing the way your brain works, specifically how different parts of your brain talk to each other. Researchers will use special brain scans, similar to advanced photographs called MRIs, to look at these brain connections. They want to find out if taking the medication changes these connections and if those changes are linked to feeling better.

What's particularly interesting about this study is that pimavanserin is designed to work differently from some other potential treatments. It's hoped to help with depression without causing any mind-altering or 'psychedelic' experiences. This study is in an early phase, meaning it's an important step in understanding if this treatment is effective and safe.

Key takeaways

This study is for major depression.
It's testing a new drug called pimavanserin.
Researchers are looking at brain activity using MRI scans.
The drug is not expected to cause psychedelic effects.
It's an early-stage study to see if the treatment works.

Who may be eligible?

To join this study, people need to be at least 18 years old. There's no upper age limit, so people of all adult ages can potentially take part.

Both men and women can participate in this research. The study is specifically for individuals who have been diagnosed with major depressive disorder.

More detailed checks would be done by the study team to make sure it's safe and suitable for someone to join, as not everyone with depression can participate in every study.

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 at least 18 years old?
Have you been diagnosed with major depressive disorder?
Are you comfortable with having MRI brain scans?
Are you willing to take study medication or a placebo?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new study medication, pimavanserin, or a placebo (a dummy pill that looks the same but contains no active drug). You wouldn't know which one you're taking, nor would the doctors overseeing your care, to make sure the results are fair.

Key parts of your participation would involve several visits to the study clinic. These visits would include medical checks and assessments by the study team. You would also have special brain scans called MRIs. These scans are important for the researchers to see if the medication is changing your brain activity. There would be follow-up appointments to monitor your well-being. The total length of your participation would be explained fully by the study team.

Potential risks and benefits

Taking part in this study might offer a potential benefit: you could receive a new treatment that might help improve your depression. However, there are also potential risks, such as side effects from the medication, whether it's pimavanserin or the placebo. You would be carefully monitored for any side effects, and all known risks would be explained to you before you agree to participate. Remember, joining a study is always voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (1)

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

—
Unverified
Spain

Common questions

What is major depressive disorder?

It's a serious medical illness where you might feel persistently sad, lose interest in activities you once enjoyed, and have other symptoms like changes in sleep, appetite, or energy.

What is pimavanserin?

Pimavanserin is a new medication being studied for depression. It works differently from typical antidepressants and is hoped to help without causing mind-altering effects.

What is a placebo?

A placebo is a 'dummy pill' that looks exactly like the study medication but contains no active drug. It helps researchers fairly compare the new drug's effects.

What are brain scans like an MRI?

An MRI is a safe and painless scan that uses magnets and radio waves to create detailed pictures of your brain. It helps researchers see how different parts of your brain are working.

Will I have a 'psychedelic' experience?

No, this study is specifically designed to test a medication that is not expected to cause 'psychedelic' or mind-altering experiences.