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RecruitingPhase 1 / Phase 2

Effects of a Sigle Dose of Ayahuasca in Patients With Psychogenic Non-epileptic Seizures: an Open Label Clinical Trial

NCT07747324 · University of Sao Paulo

Recruiting
Status
Accepting participants
Phase 1 / Phase 2
Phase
15
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Open label intervention with a single dose of ayahuasca in patients with psychogenic non-epileptic seizures (PNES)

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Seizure frequency

    Measured over Baseline, 1, 2, 3 e 4 weeks

  • Seizure frequency

    Measured over Baseline, 1, 2, 3 and 4 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 60 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
Ribeirão Preto Medical SchoolRibeirão PretoSão PauloBrazil

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT07747324 on ClinicalTrials.gov →

Last updated in the registry 2026-08-05. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits