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Study on the Effects of Psilocybin for Patients with Psychogenic Non-Epileptic Seizures (PNES)

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for individuals experiencing psychogenic non-epileptic seizures (CNEP). These seizures are episodes that resemble epileptic seizures but are not caused by electrical disruptions in the brain. The treatment being tested is a single dose of psilocybin, a substance that is being explored for its potential effects on the brain.

The purpose of the study is to understand how a single dose of psilocybin affects brain activity related to cognitive control, which is the brain’s ability to manage thoughts and actions, in patients with CNEP. This will be assessed using a technique called MRI (Magnetic Resonance Imaging), which allows researchers to see detailed images of the brain. Participants will undergo an emotional task known as the Go-No Go task, which helps measure cognitive control, before and after receiving psilocybin.

During the study, participants will receive a single dose of psilocybin in capsule form. Brain activity will be monitored before and after the treatment using MRI scans. The study will also track changes in the frequency of seizures and other related symptoms over a period of time. This research aims to provide insights into how psilocybin might influence brain function and potentially help manage symptoms in people with psychogenic non-epileptic seizures.

1 initial assessment

An initial assessment is conducted to confirm the diagnosis of psychogenic non-epileptic seizures (CNEP) using video-EEG and to ensure the patient meets the inclusion criteria.

A normal brain MRI is required as part of routine care before participation.

The patient must stop any antidepressant treatment for two weeks (or five weeks for fluoxetine) prior to the administration of psilocybin.

2 baseline evaluation

Three days before the administration of psilocybin (D-3), a functional brain MRI is performed to assess the activity of brain regions associated with cognitive control during an emotional Go-No Go task.

Resting-state functional brain MRI is also conducted to evaluate the cognitive control network and the Default-Mode Network (DMN).

The number of errors and response latency during both emotional and neutral Go-No Go tasks are recorded.

The frequency of CNEP is measured using a seizure diary for the three months prior to psilocybin administration.

The CGI-CNEP scale and dissociative symptomatology using the DES scale are assessed.

3 psilocybin administration

On day 0 (D0), a single dose of psilocybin is administered orally in the form of a capsule.

The 5D-ASC (5-Dimensional Altered States of Consciousness Questionnaire) is administered to evaluate the patient’s experience.

4 post-administration evaluation

Five days after psilocybin administration (D+5), the same assessments conducted at baseline are repeated.

Functional brain MRI is performed again to measure changes in brain activity during the emotional Go-No Go task and in resting-state networks.

The number of errors and response latency during the tasks are recorded again.

The CGI-CNEP scale and dissociative symptomatology are reassessed.

The 5D-ASC questionnaire is administered again.

5 follow-up assessments

Follow-up assessments are conducted at one month (M1) and three months (M3) after psilocybin administration.

The CGI-CNEP scale and dissociative symptomatology are measured again.

The 5D-ASC questionnaire is administered at each follow-up.

Who Can Join the Study?

  • The patient must be in a stable mood, as determined by a specific questionnaire called the MINI.
  • The patient should be able to speak and understand French.
  • The patient must have a confirmed diagnosis of psychogenic non-epileptic seizures (CNEP) through a test called video-EEG, and the condition should have been present for more than 3 months, meeting specific criteria known as DSM-5.
  • The patient should have a normal brain MRI scan during the initial evaluation, which is part of routine care.
  • The patient must not have any issues with stopping antidepressant medication for two weeks (or five weeks if taking fluoxetine) before receiving psilocybin. Other mental health medications will not be stopped.
  • The patient must have signed a consent form agreeing to participate in the study.
  • The patient should be part of or have a health insurance plan.
  • The patient must be an adult, at least 18 years old and under 60 years old.
  • The patient should be available for follow-up for 6 months.
  • The patient must be in good physical health and not have any unstable medical conditions. These conditions include heart-related issues like a history of stroke, heart attack, heart failure, irregular heartbeat, or uncontrolled high blood pressure; epilepsy and active neurological issues; hormone-related problems like thyroid issues, adrenal gland problems, type I diabetes or insulin-dependent type II diabetes, or a history of severe low blood sugar requiring hospital treatment; significant liver problems; glaucoma; and issues with the prostate or bladder.

Who Cannot Join the Study?

  • Individuals with a history of psychogenic non-epileptic seizures cannot participate. These are episodes that look like seizures but are not caused by electrical activity in the brain.
  • Participants must be within a specific age range, which is not specified here.
  • Both male and female participants are eligible, but certain criteria may exclude some individuals.
  • Individuals considered part of a vulnerable population are not eligible. This term generally refers to groups who may have limited ability to protect their own interests, such as children or those with certain disabilities.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.04.2024

Trial locations

Investigated drugs:

Psilocybin is a substance being studied for its potential effects on the brain, particularly in how it might influence cognitive control. In this trial, researchers are interested in understanding how a single dose of psilocybin affects brain activity in patients with psychogenic nonepileptic seizures (CNEP). The study uses brain imaging techniques to observe changes in brain regions that are involved in managing emotions and decision-making tasks.

Investigated diseases:

Psychogenic Non-Epileptic Seizures – These are episodes that resemble epileptic seizures but are not caused by electrical disruptions in the brain. Instead, they are often linked to psychological factors, such as stress or trauma. During an episode, a person may experience convulsions, loss of consciousness, or other seizure-like symptoms. Unlike epileptic seizures, these episodes do not show abnormal brain activity on an EEG. The condition can be challenging to diagnose because the symptoms mimic those of epilepsy. Understanding and addressing the underlying psychological issues is crucial for managing this condition.

Trial ID:
2023-509679-17-00
Protocol code:
NIMAO/2022-2/IC-01
Trial Phase:
Therapeutic exploratory (Phase II)

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