NCT07747324

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
11mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jul 2026Aug 2027

Study Start

First participant enrolled

July 1, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Non Epileptic Seizures

Outcome Measures

Primary Outcomes (2)

  • Seizure frequency

    Seizure frequency

    Baseline, 1, 2, 3 e 4 weeks

  • Seizure frequency

    Seizure frequency

    Baseline, 1, 2, 3 and 4 weeks

Study Arms (1)

Ayahuasca

EXPERIMENTAL

single oral dose of ayahuasca (1 ml/kg)

Drug: Ayahuasca

Interventions

AyahuascaDRUG

Oral dose of ayahuasca (1 ml/kg)

Ayahuasca

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ribeirão Preto Medical School

Ribeirão Preto, São Paulo, 14048900, Brazil

RECRUITING

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Professor

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 5, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

August 5, 2026

Record last verified: 2026-07

Locations

BR(1)