Comparing ayahuasca and esketamine for premenstrual symptoms
Effects of a Single Dose of Ayahuasca or Esketamine on the Menstrual Cycle and Premenstrual Symptoms: a Randomized, Double-Blind Study
This study tests whether a single oral dose of ayahuasca or esketamine can reduce premenstrual symptoms in healthy women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (Ribeirão Preto) |
| Trial ID | NCT07317232 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized interventional trial that gives a single oral dose of either ayahuasca or esketamine to healthy female volunteers with premenstrual symptoms. Participants are randomly assigned and both participants and staff are blinded to the assignment. The protocol excludes individuals with psychiatric or other medical comorbidities and is conducted at Hospital das Clínicas da FMRP-USP in Ribeirão Preto, Brazil. The registry entry does not provide detailed outcome measures or follow-up timing.
Who should consider this trial
Good fit: Healthy women who experience premenstrual symptoms, have no psychiatric or other medical comorbidities, and can attend the Ribeirão Preto site are ideal candidates.
Not a fit: Women with psychiatric disorders, other medical comorbidities, or who cannot travel to the study site would be ineligible and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this could provide a rapid, single-dose option to relieve premenstrual symptoms.
How similar studies have performed: Both ayahuasca and esketamine have shown rapid antidepressant effects in prior small studies, but their use specifically for premenstrual symptoms is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * healthy volunteers Exclusion Criteria: * psychiatric and other medical comorbidities
Where this trial is running
Ribeirão Preto
- Hospital das Clínicas da FMRP-USP — Ribeirão Preto, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.