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Evaluation of the effect of a single dose of psilocybin on neural correlates of cognitive control in patients with CNEP (psychogenic nonepileptic seizures): a single-arm, open-label pilot study.
EU CTIS ID: 2023-509679-17-00
What this study is testing
To assess by functional brain MRI the effect of psilocybin on the activity of brain regions associated with cognitive control during an emotional Go-No Go task in patients with CNEP.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Euthymic patient according to the MINI questionnaire.
- Patients receiving SSRI (Selective Serotonin Reuptake Inhibitor) or SNRI (Serotonin and Noradrenaline Reuptake Inhibitor) antidepressant therapy may continue to do so for the duration of the trial, without modification. Other psychotropic treatments will not be interrupted.
- Patient able to speak and understand French.
- Diagnosis of CNEP confirmed by video-EEG, evolving for more than 3 months and meeting DSM-5 criteria.
- Normal brain MRI during initial evaluation as part of routine care
- Patient who has signed the consent form.
You likely can't join if
- Severe risk of suicide in the opinion of the clinician.
- Patient participating in an interventional drug study.
- Patients in a period of exclusion determined by another study.
- High risk of adverse emotional or behavioural reaction according to the investigator's clinical assessment (e.g. severe personality disorder, antisocial behaviour, severe current stressors, lack of significant social support).
- Patient under court protection, guardianship or curatorship.
- Patient unable to give consent.
See the full eligibility criteria
Who can join
- Euthymic patient according to the MINI questionnaire.
- Patients receiving SSRI (Selective Serotonin Reuptake Inhibitor) or SNRI (Serotonin and Noradrenaline Reuptake Inhibitor) antidepressant therapy may continue to do so for the duration of the trial, without modification. Other psychotropic treatments will not be interrupted.
- Patient able to speak and understand French.
- Diagnosis of CNEP confirmed by video-EEG, evolving for more than 3 months and meeting DSM-5 criteria.
- Normal brain MRI during initial evaluation as part of routine care
- Patient who has signed the consent form.
- Patient affiliated or beneficiary of a health insurance plan.
- Adult patient (≥18 years) and under 60 years of age (<).
- Patient available for 6-month follow-up.
- Good physical health and absence of unstable medical pathology. These pathologies include cardiovascular comorbidities: history of stroke, myocardial infarction, heart failure, arrhythmia, uncontrolled hypertension (greater than 165/95 mmHg at screening); organic epileptic syndrome and active neurological comorbidities; endocrine pathologies (dysthyroidism and adrenal insufficiency, type I diabetes or insulin-requiring type II diabetes, history of severe hypoglycemia requiring hospital treatment); significant impairment of liver function; glaucoma; symptomatic prostate hypertrophy or bladder neck obstruction.
What rules you out
- Severe risk of suicide in the opinion of the clinician.
- Patient participating in an interventional drug study.
- Patients in a period of exclusion determined by another study.
- High risk of adverse emotional or behavioural reaction according to the investigator's clinical assessment (e.g. severe personality disorder, antisocial behaviour, severe current stressors, lack of significant social support).
- Patient under court protection, guardianship or curatorship.
- Patient unable to give consent.
- Patients for whom it is impossible to provide informed information.
- Active dependence on a substance according to the MINI questionnaire (excluding tobacco).
- Psychotropic treatment (anxiolytics, antipsychotics, hypnotics) modified in the last month.
- Patient suffering from intellectual disability.
- Lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or psychosis not otherwise specified.
- Medical conditions that would preclude safe participation in the trial; for example: Significant impairment of liver function, coronary artery disease, history of arrhythmia, heart failure, uncontrolled hypertension (greater than 165/95 mmHg at screening), history of stroke, severe asthma, hyperthyroidism, narrow angle glaucoma, uncontrolled type I or type II diabetes or a history of ketoacidosis, hyperglycaemic coma or severe hypoglycaemia with loss of consciousness.
- Family history of schizophrenia, schizoaffective disorder or type 1 bipolar disorder in first- or second-degree relatives.
- Any unstable disease or physical condition determined by history or laboratory tests (ECG, blood tests at inclusion). These conditions include cardiovascular co-morbidities: history of stroke, myocardial infarction, heart failure, arrhythmia, uncontrolled hypertension (greater than 165/95 mmHg at screening; organic epileptic syndrome and active neurological comorbidities; endocrine pathologies (dysthyroidism and adrenal insufficiency, type I diabetes or insulin-requiring type II diabetes, history of severe hypoglycaemia requiring hospital treatment); significant impairment of liver function; glaucoma; symptomatic prostatic hypertrophy or bladder neck obstruction.
- Presence of neurological co-morbidities.
- Patient on antidepressant treatment other than SSRIs or SNRIs. (Antidepressant treatments other than SSRIs or SNRIs are prohibited in the trial. Patients receiving antidepressant treatment of a different class (MAOIs, tricyclics, tetracyclics), alone or in combination, will not be included in the study).
- Women who are pregnant or breastfeeding, or who intend to become pregnant during the study.
- Insufficient contraception.
- Contraindications to magnetic resonance imaging.
- Allergy, hypersensitivity or other adverse reaction to previous use of psilocybin or other hallucinogens.
- Use of hallucinogenic substances (excluding cannabis) more than 10 times in the course of a lifetime or in the last two months, irrespective of frequency.
- Use of medication likely to interfere with the effects of psychedelics.
- Regular consumption of alcoholic beverages (>20 drinks/week).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.