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Psychogenic Nonepileptic SeizuresCRIPSYNCT06647056

Evaluation of the Effect of a Single Dose of Psilocybin on Neural Correlates of Cognitive Control in Patients With Psychogenic Nonepileptic Seizures

A study testing Psilocybin and MRI in people with Psychogenic Nonepileptic Seizures and Psilocybin, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Psychogenic non-epileptic seizures (PNES) are functional paroxysmal motor disorders that may be clinically suggestive of epilepsy but are not associated with the electroencephysiological and electroencephalographic changes of epilepsy. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Psychogenic Nonepileptic Seizures, Psilocybin
What is being tested?
Psilocybin and MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteFrance
Study dates
19 Dec 2024to 22 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Euthymic patient according to the MINI questionnaire.
  • Diagnosis of PNES confirmed by video-EEG, progressing for more than 3 months, and meeting DSM5 criteria.
  • Normal brain MRI during the assessment as part of routine care
  • No contraindication to stopping any antidepressant treatment for a fortnight (or 5 weeks for fluoxetine) prior to the administration of psilocybin. Other psychotropic treatments will not be interrupted.
  • Patient must have given their free and informed consent and signed the consent form
  • Patient must be a member of beneficiary of a health insurance plan
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  • Patient available for a total of 6 months follow-up.
  • Good physical health and absence of unstable medical pathology. These pathologies 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 (dysthyroid and adrenal insufficiency, type 1 diabetes or insulin-requiring type II diabetes, history of severe hypoglycaemia requiring hospital treatment); considerable impairment of liver function; glaucoma; symptomatic prostatic hypertrophy or bladder neck obstruction.
  • Ability to understand and speak French

Who cannot join

  • Serious risk of suicide according to the clinician opinion.
  • High risk of adverse emotional or behavioural reaction as clinically assessed by the investigator (e.g. severe personality disorder, antisocial behaviour, severe current stress factors, lack of consequent social support).
  • Active dependence on a substance according to the MINI questionnaire (excluding tobacco).
  • Psychotropic treatment (anxiolytics, antipsychotics, hypnotics) modified in the last month.
  • Patient with intellectual disability.
  • A lifetime history of bipolar disorder, schizophrenia, schizoaffective disorder or psychosis not otherwise specified.
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  • 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, arrythmia, uncontrolled hypertension (greater than 165/95 mmHg at screening); organic epileptic syndrome and active neurological comorbidities; endocrine pathologies (dysthyroid and adrenal disorders, type I diabetes or insulin-requiring type II diabetes, history of severe hypoglycaemia requiring hospital treatment); considerable impairment of liver function; glaucoma, symptomatic prostatic hypertrophy or bladder neck obstruction.
  • Presence of neurological comorbidities.
  • Medical conditions that would preclude safe participation in the trial; for example: considerable impairment of liver function, coronary artery disease, history of arrythmia, heart failure, uncontrolled hypertension (greater than 165/95 mmHg at screening). History of stroke, severe asthma, hyperthyroid, narrow angle glaucoma, uncontrolled type I or type II diabetes or history of ketoacidosis, hyperglycaemic coma or severe hypoglycaemia with loss of consciousness.
  • Participants planning to donate sperm within three months of psilocybin administration.
  • Participants having sexual intercourse that could lead to pregnancy and who do not agree to use a highly effective contraceptive method (contraceptive ring, surgical contraception, implant, patch, contraceptive pill, male and female condoms, IUD) throughout their participation in the study and for at least three months after administration of psilocybin.
  • Positive serum pregnancy test at inclusion for participants of childbearing age NB: serum pregnancy test will be performed prior to administration of psilocybin.
  • Contraindications to magnetic resonance imaging.
  • Allergy, hypersensitivity or other adverse reaction to previous use of psilocybin or other hallucinogens.
  • Consumption of hallucinogenic substances (excluding cannabis) more than 10 times in a lifetime or in the last 2 months, regardless of frequency.
  • Use of medication likely to interfere with the effects of psychedelics.
  • Regular consumption of alcoholic beverages (>20 drinks/week).
  • Any other major clinically considerable concomitant disease which, in the opinion of the investigator, may interfere with the interpretation of the results of the study or constitute a risk to the health of the participant, should they take part in the study.
  • Patient with a prolonged QTc interval (interval >450 ms for men and >470 ms for women)
  • Patient taking part in an interventional drug study.
  • Patient in a period of exclusion determined by another study.
  • Patient under court protection, guardianship or curatorship.
  • Patient unable to give consent.
  • Patient to whom it is impossible to communicate informed information
  • Patient with a positive pregnancy test prior to psilocybin administration.
  • Any patient who has been hospitalised on an outpatient or inpatient basis between the date of inclusion and the administration of psilocybin.
  • Any patient who has made a known, interrupted or aborted suicide attempt between the date of inclusion and the administration of psilocybin.
  • Any patient who has expressed suicidal ideation associated with the planning of a suicidal act (active suicidal ideation) between the date of inclusion and the administration of psilocybin.

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU de Nîmes, Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

Psychogenic non-epileptic seizures (PNES) are functional paroxysmal motor disorders that may be clinically suggestive of epilepsy but are not associated with the electroencephysiological and electroencephalographic changes of epilepsy. Thus, hyper-connectivity of the regions of the default mode network (DMN) linked to executive control could be involved in the impairment of cognitive control capacities in patients suffering from PNES. Also, the HYCORE study (NCT02329626), showed that dysregulation of frontal regions involved in attentional and emotional regulation is correlated with motor symptoms in patients with functional neurological disorders.

The researchers of this study hypothesized that psilocybin would improve cognitive control in patients with PNES.

Being tested
Psilocybin, MRI
Medical subject headings
Psychogenic Nonepileptic Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsilocybinDrug

    Administration of psilocybin 25 mg

  • MRIOther

    Two standard MRI + fMRI scans before (D-3) and after (D5) treatment

Study groups in NCT06647056
Study groupRoleWhat they receive
Patients with PNESExperimentalNot described
Receives: Drug: Psilocybin; Other: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emotional distraction in PNES patients receiving psilocybin

    Fluctuation du signal BOLD (Blood-oxygen level dependence) during a Go-No Go test

    Measured: Three days before psilocybin treatment

  2. Emotional distraction in PNES patients receiving psilocybin

    Fluctuation du signal BOLD (Blood-oxygen level dependence) during a Go-No Go test

    Measured: Five days after psilocybin treatment

Secondary outcomes (22)

  1. Resting-state activity in brain regions involved in cognitive control in PNES patients receiving psilocybin

    Fluctuation of the BOLD (Blood-oxygen level dependent) signal for each independent component (Image grey levels).

    Measured: Three days before psilocybin treatment

  2. Resting-state activity in brain regions involved in cognitive control in PNES patients receiving psilocybin

    Fluctuation of the BOLD (Blood-oxygen level dependent) signal for each independent component (Image grey levels).

    Measured: Five days after psilocybin treatment

  3. Resting-state activity in brain regions of the default mode network (DMN) in patients with PNES receiving psilocybin.

    Blood-oxygen level dependent (BOLD) signal synchronisation levels in brain regions DMN (grey levels of the image).

    Measured: Three days before psilocybin treatment

  4. Resting-state activity in brain regions of the default mode network (DMN) in patients with PNES receiving psilocybin.

    Blood-oxygen level dependent (BOLD) signal synchronisation levels in brain regions DMN (grey levels of the image).

    Measured: Five days after psilocybin treatment

  5. Cognitive control abilities in patients with PNES receiving psilocybin

    emotional Go-No Go error rate (%)

    Measured: Three days before psilocybin treatment

  6. Cognitive control abilities in patients with PNES receiving psilocybin

    emotional Go-No Go error rate (%)

    Measured: Five days after psilocybin treatment

  7. Cognitive control abilities in patients with PNES receiving psilocybin

    neutral Go-No Go task response latency (ms)

    Measured: Three days before psilocybin treatment

  8. Cognitive control abilities in patients with PNES receiving psilocybin

    neutral Go-No Go task response latency (ms)

    Measured: Five days after psilocybin treatment

  9. Number of PNES over a 3-month period in patients with PNES receiving psilocybin

    Number

    Measured: Day 0

  10. Number of PNES over a 3-month period in patients with PNES receiving psilocybin

    Number

    Measured: Month 3

  11. Functional impact of PNES in patients with PNES receiving psilocybin

    Clinical Global Impression: Score 0-7; cut-off: 4 = unchanged or worse and the secondary effects take over the therapeutic effects

    Measured: Three days before psilocybin treatment

  12. Functional impact of PNES in patients with PNES receiving psilocybin

    Clinical Global Impression: Score 0-7; cut-off: 4 = unchanged or worse and the secondary effects take over the therapeutic effects

    Measured: Five days after psilocybin treatment

  13. Functional impact of PNES in patients with PNES receiving psilocybin

    Clinical Global Impression: Score 0-7; cut-off: 4 = unchanged or worse and the secondary effects take over the therapeutic effects

    Measured: Month 1

  14. Functional impact of PNES in patients with PNES receiving psilocybin

    Clinical Global Impression: Score 0-7; cut-off: 4 = unchanged or worse and the secondary effects take over the therapeutic effects

    Measured: Month 3

  15. Dissociative symptoms in patients with PNES receiving psilocybin

    Dissociation Experience Scale: Score 0-100; cut-off: 30 or more shows the presence of dissociative troubles.

    Measured: Three days before psilocybin treatment

  16. Dissociative symptoms in patients with PNES receiving psilocybin

    Dissociation Experience Scale: Score 0-100; cut-off: 30 or more shows the presence of dissociative troubles.

    Measured: Five days after psilocybin treatment

  17. Dissociative symptoms in patients with PNES receiving psilocybin

    Dissociation Experience Scale: Score 0-100; cut-off: 30 or more shows the presence of dissociative troubles.

    Measured: Month 1

  18. Dissociative symptoms in patients with PNES receiving psilocybin

    Dissociation Experience Scale: Score 0-100; cut-off: 30 or more shows the presence of dissociative troubles.

    Measured: Month 3

  19. Tolerance of psilocybin in patients with PNES receiving psilocybin

    5-Dimensional Altered States of Consciousness Rating Scale: Score 0-100; more than 25 = higher probability to have a dissociative trouble.

    Measured: Day 0

  20. Tolerance of psilocybin in patients with PNES receiving psilocybin

    5-Dimensional Altered States of Consciousness Rating Scale: Score 0-100; more than 25 = higher probability to have a dissociative trouble.

    Measured: Five days after psilocybin treatment

  21. Tolerance of psilocybin in patients with PNES receiving psilocybin

    5-Dimensional Altered States of Consciousness Rating Scale: Score 0-100; more than 25 = higher probability to have a dissociative trouble.

    Measured: Month 1

  22. Tolerance of psilocybin in patients with PNES receiving psilocybin

    5-Dimensional Altered States of Consciousness Rating Scale: Score 0-100; more than 25 = higher probability to have a dissociative trouble.

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2024
  2. Study start19 Dec 2024
  3. Primary completion3 Jan 2025
  4. Study completion22 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06647056
Sponsor's protocol ID
NIMAO/2022-2/IC01
Acronym
CRIPSY
Status last verified
Aug 2025
First submitted
16 Oct 2024
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Psilocybin and MRI in people with Psychogenic Nonepileptic Seizures and Psilocybin, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotional distraction in PNES patients receiving psilocybin (time frame: Three days before psilocybin treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06647056.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.

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