Non Epileptic Seizures
Conditions
Brief summary
Open label intervention with a single dose of ayahuasca in patients with psychogenic non-epileptic seizures (PNES)
Interventions
DRUGAyahuasca
Oral dose of ayahuasca (1 ml/kg)
Sponsors
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 to 60 with documented PNES (confirmed via VEEG), without a diagnosis of comorbid epilepsy, and currently receiving follow-up care at outpatient clinics. To enroll in the study, patients must undergo a gradual reduction and discontinuation of any psychotropic medications (antidepressants, antipsychotics, benzodiazepines, or mood stabilizers/anticonvulsants) they are currently taking, in order to avoid drug interactions with-or influence on-the effects of ayahuasca.
Exclusion criteria
* Patients who have not experienced psychogenic seizures in the last 3 months; patients diagnosed with epilepsy; patients who refuse to reduce or discontinue their current psychotropic medications; patients with a history of prior ayahuasca use; patients with a history of substance use disorder; patients who refuse to sign the Informed Consent Form; patients with schizophrenia or other psychotic disorders and/or impaired reality testing; and pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizure frequency | Baseline, 1, 2, 3 e 4 weeks | Seizure frequency |
Countries
Brazil
Outcome results
None listed