MLS101 Study in PMDD

NCT07818720 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: MLS101-104
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PMDD; Premenstrual Dysphoric Disorder ( PMDD)

Keywords

PMDD; PMS; Premenstrual Dysphoric Disorder; psilocybin

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v6.0

  Safety and tolerability of MLS101 and placebo from baseline through Visit 11/Final Telehealth Visit (Day 44 ± 5) as assessed by type, frequency, severity, timing, and relationship to MLS101 of any adverse events (AEs), adverse events of special interest (AESIs) serious adverse events (SAEs)

  From baseline through the final telehealth visit at week 11

Secondary Outcomes (10)

• No change from baseline to end of study in mitral valve leaflet thickness as measured by transthoracic echocardiogram

  From baseline to week 11

• Change in Maximum Plasma Concentreation (Cmax)

  Day 1 of treatment only

• Change in subjective psychedelic experience from pretreatment to 8 hours after treatment

  From pretreatment to 8 hours after treatment each treatment day

• Participant reported drug liking

  Once at the end of treatment

• No change from baseline in Standardized Field Sobriety Test (SFST)

  From baseline pretreatment to 8 hours after treatment

Study Arms (4)

Placebo group will receive a total of 6 intermittent doses of placebo

PLACEBO COMPARATOR

Drug: Placebo capsules

MLS101 2 mg group will receive a total of 6 intermittent doses at 2 mg/dose

ACTIVE COMPARATOR

Drug: MLS101 psilocybin

MLS101 4 mg group will receive a total of 6 intermittent doses at 4 mg/dose

ACTIVE COMPARATOR

Drug: MLS101 psilocybin

MLS101 8 mg group will receive a total of 6 intermittent doses at 8 mg/dose

ACTIVE COMPARATOR

Drug: MLS101 psilocybin

Interventions

MLS101 psilocybin DRUG

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

MLS101 2 mg group will receive a total of 6 intermittent doses at 2 mg/dose; MLS101 4 mg group will receive a total of 6 intermittent doses at 4 mg/dose; MLS101 8 mg group will receive a total of 6 intermittent doses at 8 mg/dose

Placebo capsules DRUG

Placebo group will receive a total of 6 intermittent doses of placebo

Placebo group will receive a total of 6 intermittent doses of placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Provides informed consent for participating in the study
• Biologically female participants 18-50 years of age (inclusive) at Screening and premenopausal
• Body mass index (BMI) ≥ 18.5 and \< 40.0 kg/m2
• Menstrual cycle duration of 24-35 days (inclusive) reported at Screening
• Menstrual cycles are sufficiently regular to allow estimation of menses onset with reasonable accuracy based on participant's reported history and the Investigator's assessment
• Participant has an existing diagnosis of PMDD and history of at least one prior or current medically-supervised treatment for PMDD
• CGI-S ≥ 4 for late luteal phase PMDD symptom severity and associated impairment at Screening
• Mean VAS score ≥ 50 on any one of the 4 core symptoms of PMDD at Screening, as measured using the first 4 items on the PMTS-VAS
• Participant is using a medically acceptable form of birth control for at least 8 weeks prior to receiving first dose of study drug and agrees to continue using medically acceptable birth control for at least 4 weeks post last dose in the study. Medically acceptable birth control methods include double-barrier methods used with spermicide, copper or low-dose levonorgestrel-releasing IUD, participant has had tubal ligation, participant is in a monogamous relationship with a vasectomized male or with another female, or participant is celibate as part of her lifestyle and will remain so throughout the study. (Note that for this study, oral, subdermal, transdermal, injectable, and vaginal ring hormonal contraceptives are not allowed).
• If a participant is currently taking SSRI treatment, it must have been maintained as a stable monotherapy for at least 3 months prior to Screening with intent to continue unchanged for the duration of the study.

You may not qualify if:

• Currently meets DSM-5 criteria for MDD, GAD, Panic Disorder, OCD, Anorexia, Bulimia, Binge Eating Disorder, Borderline Personality Disorder, or Anti-Social Personality Disorder, based on M.I.N.I.
• History of meeting DSM-5 criteria for Major Depressive Episode within the past 6 months from Screening
• History of meeting DSM-5 criteria for Panic Disorder, OCD, Anorexia, Bulimia, Binge Eating Disorder, Anti-Social Personality Disorder, or Borderline Personality Disorder within 24 months from Screening
• Lifetime history of any psychosis or mania not attributable to substance use
• First degree relative with schizophrenia, schizoaffective disorder or bipolar I disorder
• Confirmed to be in perimenopause, or diagnosis of Polycystic Ovary Syndrome based on ACOG/Rotterdam criteria, or diagnosis of symptomatic uterine fibroids
• PMDD symptoms attributable to, or exacerbated by, hormonal contraceptives/treatments
• Participant plans to start any new treatment for PMDD, or to stop any ongoing SSRI treatment during the study
• Use of any herbal or supplement with known serotonin-enhancing properties (e.g. St. John's Wort, L-tryptophan, 5-hydroxytryptophan) within the past 3 months at Screening
• Use of any hormonal contraceptive that works primarily by suppression of ovulation, for the past month at Screening. Therefore, use of oral, subdermal, transdermal, injectable, and vaginal ring hormonal contraceptives is excluded. (However, copper IUDs and hormonal IUDs that release low-dose levonorgestrel are acceptable.)
• Use of any non-SSRI antidepressant, antipsychotic, or anticonvulsant within the past 3 months
• Exposure to a neurosteroid, whether marketed or in a clinical trial, during the past 12 months
• Requires ongoing pharmacologic treatment for Attention-deficit/hyperactivity disorder (ADHD)
• Suicidal ideation with intent and plan, suicide attempt, or psychiatric hospitalization during the past 12 months, or an answer of "yes" to Question 4 or 5 on the Baseline/Screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Use of a classic (serotonergic) psychedelic in any form and at any dose in the past 6 months

Sponsors & Collaborators

• MycoMedica Life Sciences PBC: lead

MeSH Terms

Conditions

Premenstrual Dysphoric Disorder

Condition Hierarchy (Ancestors)

Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Executive Director of Clinical Operations

CONTACT

(732) 690-3185; sbasim@mycomedica.com

Heather Director of Clinical Operations

CONTACT

14349963378; hlothamer@mycomedica.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 14, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share