Single dose ayahuasca in adults with psychogenic non-epileptic seizures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study will administer one dose of ayahuasca to adults aged 18 to 60 with documented PNES and no epilepsy. Participants must gradually reduce and discontinue current psychotropic medications to avoid interactions. The trial is open-label and combines Phase 1 and Phase 2 elements to assess safety and potential clinical effects in an outpatient setting at Ribeirão Preto Medical School, University of Sao Paulo. Outcomes will focus on safety and any changes in seizure frequency or related symptoms. Results may inform future research on psychoactive therapies for PNES.

Why it matters

Who can join: the full rules

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 it's running

• Ribeirão Preto Medical School
  Ribeirão Preto, São Paulo, Brazil Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SPN-817 for adults with treatment-resistant epilepsy

  We will try SPN-817 to see if it is safe and tolerable for adults whose seizures haven't responded to standard treatments.

  Recruiting at 8 sites Phase 2 Supernus Pharmaceuticals, Inc. · Jacksonville, Florida and 9 other locations · NCT05518578

• Analyzing brain imaging biomarkers in patients with cerebral cavernous malformation-related epilepsy

  This study is trying to see if brain scans can help find signs of iron buildup in people with cerebral cavernous malformation and epilepsy, which could improve how we manage their condition.

  Recruiting at 2 sites Beijing Tiantan Hospital · Beijing, Beijing Municipality and 1 other locations · NCT04076449

• Understanding treatment effects in adult patients with status epilepticus

  This study looks at how different treatments for adults with status epilepticus can improve their outcomes by tracking patient data from two hospitals.

  Recruiting at 2 sites University Hospital, Basel, Switzerland · Aarau and 1 other locations · NCT04204863

• Retraining and Control Therapy for adults with non-epileptic seizures

  This study is testing a new therapy called Retraining and Control Therapy to see if it can help adults with non-epileptic seizures feel more in control and reduce their worries about their symptoms.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT06570954

• Creating a treatment program for functional neurological disorder

  This study is trying to create a new treatment plan for people with functional neurological disorder by bringing together different types of therapy to see if it helps both kids and adults feel better.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT06362161

• Therapy to improve control and reduce symptoms in children with non-epileptic seizures

  This study is testing a new therapy called ReACT to see if it can help children aged 11-18 with non-epileptic seizures feel more in control and reduce their symptoms.

  Recruiting University of Alabama at Birmingham · Birmingham, Alabama · NCT06007053

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.