Healthy Women Volunteers
Conditions
Brief summary
Double-blind, randomized trial comparing a single dose of oral ayahuasca or esketamine on premenstrual symptoms.
Interventions
DRUGAyahuasca
oral ayahuasca
DRUGEsketamine
oral esketamine
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy volunteers
Exclusion criteria
* psychiatric and other medical comorbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Premenstrual Symptom Tracking Instrument (PSST) | From enrollment to the end of treatment at 3 weeks | higher scores mean a worse outcome |
Countries
Brazil
Outcome results
None listed