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.

Phase 1

• Conditions: psychogenic non-epileptic seizures; MedDRA version: 21.0Level: LLTClassification code: 10072463Term: Non-epileptic seizure Class: 10029205; MedDRA version: 22.1Level: PTClassification code: 10058895Term: Psychogenic seizure Class: 100000004852; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: CTIS2023-509679-17-00
• Lead Sponsor: Centre Hospitalier Universitaire De Nimes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Euthymic patient according to the MINI questionnaire., 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, No contraindication to stopping antidepressant treatment for two weeks (or five weeks for fluoxetine) prior to psilocybin administration. Other psychotropic treatments will not be interrupted., 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.

Exclusion Criteria

Severe risk of suicide in the opinion of the clinician., 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., 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)., 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., 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified