Clinical TrialAyahuascaEsketamineRecruiting

Ayahuasca, Esketamine and Premenstrual Symptoms

This randomized, double‑blind trial (n=20) will assess the effects of a single oral dose of ayahuasca versus oral esketamine on the menstrual cycle and premenstrual symptoms in healthy women aged 18–65, with the primary outcome measured by the Premenstrual Symptom Tracking Instrument (PSST) from enrolment to three weeks. Participants will be allocated in a parallel design to an experimental arm receiving oral ayahuasca or an active comparator arm receiving oral esketamine under double‑blind conditions. The study is described as basic science, enrols healthy female volunteers without psychiatric or other medical comorbidities, has estimated enrolment of 20, and is scheduled to start on 20 December 2025 with completion anticipated in July 2026.

Target Enrollment
20 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on premenstrual symptoms.

Study Arms & Interventions

ayahuasca

experimental

oral ayahuasca

Interventions

  • Ayahuasca

esketamine

active comparator

oral esketamine

Interventions

  • Esketamine

Participants

Ages
1865
Sexes
female

Inclusion Criteria

  • healthy volunteers

Exclusion Criteria

  • psychiatric and other medical comorbidities

Study Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment20 participants
  • Timeline
    Start: 2025-12-20
    End: 2026-07-01
  • Compounds

Study Team

Sponsors & Collaborators

Locations

Hospital das Clínicas da FMRP-USPRibeirão Preto, Brazil

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