NCT07317232

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

December 19, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 19, 2025

Last Update Submit

December 19, 2025

Conditions

Healthy Women Volunteers

Outcome Measures

Primary Outcomes (1)

  • Premenstrual Symptom Tracking Instrument (PSST)

    higher scores mean a worse outcome

    From enrollment to the end of treatment at 3 weeks

Study Arms (2)

ayahuasca

EXPERIMENTAL

oral ayahuasca

Drug: Ayahuasca

esketamine

ACTIVE COMPARATOR

oral esketamine

Drug: Esketamine

Interventions

AyahuascaDRUG

oral ayahuasca

Also known as: aya
ayahuasca
EsketamineDRUG

oral esketamine

Also known as: ketamine
esketamine

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailshealthy women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • psychiatric and other medical comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da FMRP-USP

Ribeirão Preto, Brazil

RECRUITING

MeSH Terms

Interventions

EsketamineKetamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 5, 2026

Study Start

December 20, 2025

Primary Completion

June 1, 2026

Study Completion

July 1, 2026

Last Updated

January 5, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)