U.S., Sept. 15 -- ClinicalTrials.gov registry received information related to the study (NCT07818720) titled 'MLS101 Study in PMDD' on Aug. 25.
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.
Study Start Date: Dec., 2026
Study Type: INTERVENTIONAL
Condition:
Premenstrual Dysphoric Disorder ( PMDD)
PMDD
Intervention:
DRUG: MLS101 psilocybin
Patients will be randomized in a 1:1:1:1 ratio to receive 6 doses of either placebo or MLS101 at 2 mg, 4 mg, or 8 mg
DRUG: Plac...