MLS101 Study in PMDD
brief summary
The goal of this clinical trial is to learn if MLS101 (psilocybin) is a possible treatment for women with Premenstrual Dysphoric Disorder (PMDD). The main question it aims to answer is: • Test the safety and tolerability of the study drug, MLS101 in premenopausal women (ages 18-50 inclusive) with PMDD.
detailed description
The purpose of this trial is to investigate the safety and tolerability of intermittent low-dose MLS101 (psilocybin) 2mg, 4mg, and 8mg versus placebo in participants with PMDD. These doses are less than one third of the doses typically administered in high-dose psilocybin studies.
The study will enroll premenopausal women, ages 18-50 (inclusive) with an existing diagnosis of PMDD and history of having tried at least 1 prior treatment for PMDD. There is an initial Screening/Preparation Period of up to 2-5 weeks. The 16-day Treatment Period will span the luteal phase of 1 menstrual cycle. During this time, participants will receive 6 doses of MLS101 capsules in the clinic approximately every 3 days. After the Treatment Period, there is a Follow-up Period of approximately 1 month.
Participants will be monitored after receiving each dose for at least 8 hours in the clinic and must meet specified criteria before discharge. All participants will be escorted home by a companion or via concierge care service after each dosing session.
official title
A Phase 1b Study to Evaluate the Safety and Tolerability of MLS101 Treatment for Premenstrual Dysphoric Disorder (PMDD)