Health TrialsbyHealthPanel

MLS101 Study in PMDD

ConditionsPremenstrual Dysphoric Disorder ( PMDD)PMDD
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorMycoMedica Life Sciences PBC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

History of meeting DSM-5 criteria for Substance or Alcohol Use Disorder in the last 2 years at Screening (Note: mild recreational cannabis use in the judgment of the Investigator, that does not meet criteria for moderate or severe Substance Use Disorder, is not exclusionary)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Placebo capsules

    Drug

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

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: Placebo group will receive a total of 6 intermittent doses of placeboPlacebo comparator 1 intervention
Group B: MLS101 2 mg group will receive a total of 6 intermittent doses at 2 mg/doseActive comparator 1 intervention
Group C: MLS101 4 mg group will receive a total of 6 intermittent doses at 4 mg/doseActive comparator 1 intervention
Group D: MLS101 8 mg group will receive a total of 6 intermittent doses at 8 mg/doseActive comparator 1 intervention

Trial outcomes

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)

Time frame
From baseline through the final telehealth visit at week 11

Secondary outcomes

1

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

Baseline transthoracic echocardiogram to measure mitral valve leaflet thickness. Mitral valve leaflet thickness of \< 3 mm is normal, whereas \>3 mm in mitral valve leaflet thickness is considered abnormal in an echocardiogram.

Time frame
From baseline to week 11
2

Change in Maximum Plasma Concentreation (Cmax)

Blood samples will be collected at 30 minutes, and 1, 2, 3, 4, 6, and 8 hours after a single dose of study drug to determine the change in Cmax

Time frame
Day 1 of treatment only
3

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

The Acute Subjective Effects Scale (ASES) is a visual analog scale from 0-10 with 0 being no psychedelic experience and 10 being the most intense. Participants will have to score less than or equal to 2 to be considered recovered from treatment effects.

Time frame
From pretreatment to 8 hours after treatment each treatment day
4

Participant reported drug liking

Drug liking will be assessed using the drug Liking Visual Analog Scale (VAS) which is a scale from 0 which indicates strong dislike to 100 which indicates strong liking and a score of 50 is neutral.

Time frame
Once at the end of treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MycoMedica Life Sciences PBC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: