Clinical TrialAnxiety DisordersPlaceboLSDLSDRecruiting

A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)

This Phase III, multicenter, randomised, double-blind, placebo-controlled trial (n=250) will evaluate the efficacy and safety of oral MM120 (LSD D-Tartrate) compared to placebo in adults diagnosed with generalized anxiety disorder (GAD). The study aims to assess changes in anxiety levels, primarily measured by the Hamilton Anxiety Rating Scale (HAM-A) total score, over a 12-week treatment period, followed by a 40-week open-label extension. Participants aged 18 to 74 years with a confirmed GAD diagnosis and a minimum HAM-A score of 20 will be enrolled. The trial consists of three arms: one receiving a placebo, one receiving 50 µg of MM120, and another receiving 100 µg of MM120. The initial 12-week phase will involve randomised, single-dose administration, after which participants will have the opportunity for open-label treatment based on safety and symptom severity criteria during the extension phase. The study is set to begin in January 2025 and aims to complete by May 2027.

Target Enrollment
250 participants
Study Type
Phase III interventional
Design
Randomized, double Blind

Detailed Description

A Phase 3, Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder - Panorama

Study Arms & Interventions

Arm 1 - Placebo

inactive

A substance that is designed to have no therapeutic value

Interventions

  • Placebo

Arm 2 - 50µg MM120 (LSD D-Tartrate)

inactive

A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Interventions

  • LSD50
    via Oral• single dose

Arm 3 - 100µg MM120 (LSD D-Tartrate)

experimental

A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Interventions

  • LSD50
    via Oral• single dose

Participants

Ages
18 – 74
Sexes
All

Inclusion Criteria

  • 1. Diagnosis of GAD per DSM-5
  • 2. Male or female aged 18 to 74
  • 3. HAM-A Total Score ≥20

Exclusion Criteria

  • 1. Certain psychiatric disorders (other than generalized anxiety disorder)
  • 2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
  • 3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
  • 4. Any clinically significant unstable illness

Study Details

  • Status
    Recruiting
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment250 participants
  • Timeline
    Start: 2025-01-29
    End: 2027-05-01
  • Compounds
    PlaceboLSDLSD
  • Topic
    Anxiety Disorders

Study Team

Sponsors & Collaborators

Locations

Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
Psychedelic Science Institute — Los Angeles, California, United States
West Los Angeles VA Medical Center — Los Angeles, California, United States
Cenexel-CNS — Torrance, California, United States
Bradenton Research Center, Inc. — Bradenton, Florida, United States
Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States
Atlanta Center for Medical Research — Atlanta, Georgia, United States
Sheppard Pratt Health System — Towson, Maryland, United States
Adams Clinical Boston — Boston, Massachusetts, United States
Princeton Medical Institute — Princeton, New Jersey, United States
University of Cincinnati Psychiatry- Anxiety Disorders Research Program — Cincinnati, Ohio, United States
Neuro-Behavioral Clinical Research, Inc. — North Canton, Ohio, United States
Austin Clinical Trial Partners — Austin, Texas, United States
Cedar Clinical Research — Murray, Utah, United States
Core Clinical Research — Everett, Washington, United States
A-shine s.r.o. — Pilsen, Czechia
Institut Neuropsychiatricke Pece (INEP) — Prague, Czechia
Psyon s.r.o. — Prague, Czechia
Cabinet Dr.Desbonnet : Résidence Saint Michel — Douai, France
CMME — Paris, France
GHU Paris Psychiatrie et Neurosciences — Paris, France
Centre Hospitalier du Rouvray — Sotteville-lès-Rouen, France
Department of Psychiatry and Psychotherapy Campus Charité Mitte Charité Universitätsmedizin Berlin — Berlin, Germany
OVID Clinic Berlin — Berlin, Germany
Central Institute of Mental Health — Mannheim, Germany
Klinik für Psychiatrie und Psychotherapie, Abt: Allgemeine Psychiatrie und Psychotherapie — Tübingen, Germany
Centrum Badan Klinicznych PI-House sp. z o.o. — Gdansk, Poland
Department of Psychiatry, UCK — Gdansk, Poland
Neuroclin Glasgow — Glasgow, United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, St. Nicholas Hospital — Gosforth, United Kingdom
4 Medical Clinical Solutions — London, United Kingdom
Clerkenwell Health - Baker Street — London, United Kingdom
Clerkenwell Health — London, United Kingdom
South London and Maudsley NHS Foundation Trust of The Maudsley Hospital — London, United Kingdom
4 Medical Clinical Solutions — Manchester, United Kingdom
St George's Community Health Centre — Sheffield, United Kingdom

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