Recruiting NCT07747324
Effects of a Sigle Dose of Ayahuasca in Patients With Psychogenic Non-epileptic Seizures: an Open Label Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ayahuasca.
- Who it may be relevant to
- Registry conditions: Non Epileptic Seizures. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Open label intervention with a single dose of ayahuasca in patients with psychogenic non-epileptic seizures (PNES)
Interventions
- Drug Ayahuasca
Oral dose of ayahuasca (1 ml/kg)
Primary outcome measures
- Seizure frequency [Time frame: Baseline, 1, 2, 3 e 4 weeks]
- Seizure frequency [Time frame: Baseline, 1, 2, 3 and 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Ribeirão Preto Medical School — Ribeirão Preto
Identifiers
NCT: NCT07747324 · CAAE: 95270126.9.0000.5440