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

Last updated: September 3, 2026
Sponsor: Definium Therapeutics US, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Panic Disorders

Anxiety Disorders

Mood Disorders

Treatment

DT120

MM120 (LSD D-Tartrate)

Placebo

Clinical Study ID

NCT06809595
MM120-301
  • Ages 18-74
  • All Genders

Study Summary

A Phase 3, Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Generalized Anxiety Disorder - Panorama

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of GAD per DSM-5

  2. Male or female aged 18 to 74

  3. HAM-A Total Score ≥20

Exclusion

Exclusion Criteria:

  1. Certain psychiatric disorders (other than generalized anxiety disorder)

  2. First degree relative with or lifetime history of a psychotic disorder or bipolardisorder

  3. Current diagnosis of alcohol or substance use disorder (excluding nicotine andcaffeine)

  4. Any clinically significant unstable illness

Study Design

Total Participants: 245
Treatment Group(s): 3
Primary Treatment: DT120
Phase: 3
Study Start date:
January 29, 2025
Estimated Completion Date:
May 31, 2027

Study Description

The study will enroll up to 375 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM A total score of at least 20 at Screening and Baseline without clinically relevant medical or psychiatric history.

The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating DT120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with DT120 based on pre-specified safety and symptom severity criteria.

Connect with a study center

  • A-shine s.r.o.

    Pilsen,
    Czechia

    Site Not Available

  • Institut Neuropsychiatricke Pece (INEP)

    Prague,
    Czechia

    Site Not Available

  • Psyon s.r.o.

    Prague,
    Czechia

    Site Not Available

  • Psyon s.r.o.

    Prague 3067696,
    Czechia

    Active - Recruiting

  • Cabinet Dr.Desbonnet : Résidence Saint Michel

    Douai,
    France

    Site Not Available

  • Hôpital Conception, CIC Centre, bat néphrologie 3eme étage

    Marseille,
    France

    Site Not Available

  • CMME

    Paris,
    France

    Site Not Available

  • GHU Paris Psychiatrie et Neurosciences

    Paris,
    France

    Site Not Available

  • CMME

    Paris 2988507,
    France

    Active - Recruiting

  • Centre Hospitalier du Rouvray

    Sotteville-lès-Rouen,
    France

    Site Not Available

  • Department of Psychiatry and Psychotherapy Campus Charité Mitte Charité Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • OVID Clinic Berlin

    Berlin,
    Germany

    Site Not Available

  • Department of Psychiatry and Psychotherapy Campus Charité Mitte Charité Universitätsmedizin Berlin

    Berlin 2950159,
    Germany

    Active - Recruiting

  • Central Institute of Mental Health

    Mannheim,
    Germany

    Site Not Available

  • Klinik für Psychiatrie und Psychotherapie, Abt: Allgemeine Psychiatrie und Psychotherapie

    Tübingen,
    Germany

    Site Not Available

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk,
    Poland

    Site Not Available

  • Department of Psychiatry, UCK

    Gdansk,
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI-House sp. z o.o.

    Gdansk 3099434,
    Poland

    Active - Recruiting

  • Department of Affective and Psychotic Disorders, Central Teaching Hospital, Medical University of Lodz

    Lodz,
    Poland

    Site Not Available

  • Neuroclin Glasgow

    Glasgow,
    United Kingdom

    Site Not Available

  • Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, St. Nicholas Hospital

    Gosforth,
    United Kingdom

    Site Not Available

  • 4 Medical Clinical Solutions

    London,
    United Kingdom

    Site Not Available

  • Clerkenwell Health

    London,
    United Kingdom

    Site Not Available

  • Clerkenwell Health - Baker Street

    London,
    United Kingdom

    Site Not Available

  • South London and Maudsley NHS Foundation Trust of The Maudsley Hospital

    London,
    United Kingdom

    Site Not Available

  • Clerkenwell Health

    London 2643743,
    United Kingdom

    Active - Recruiting

  • Clerkenwell Health - Baker Street

    London 2643743,
    United Kingdom

    Active - Recruiting

  • South London and Maudsley NHS Foundation Trust of The Maudsley Hospital

    London 2643743,
    United Kingdom

    Active - Recruiting

  • 4 Medical Clinical Solutions

    Manchester,
    United Kingdom

    Site Not Available

  • St George's Community Health Centre

    Sheffield,
    United Kingdom

    Site Not Available

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • New School Research

    Los Angeles, California 90004
    United States

    Site Not Available

  • Psychedelic Science Institute

    Los Angeles, California 90004
    United States

    Site Not Available

  • West Los Angeles VA Medical Center

    Los Angeles, California 90073
    United States

    Site Not Available

  • West Los Angeles VA Medical Center

    Los Angeles 5368361, California 5332921 90073
    United States

    Site Not Available

  • Bradenton Research Center, Inc.

    Bradenton, Florida 34205
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc

    Orlando, Florida 32801
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Sheppard Pratt Health System

    Towson, Maryland 21204
    United States

    Site Not Available

  • Adams Clinical Boston

    Boston, Massachusetts 02116
    United States

    Site Not Available

  • Copley Clinical

    Boston, Massachusetts 02116
    United States

    Active - Recruiting

  • Princeton Medical Institute

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • University of Cincinnati Psychiatry- Anxiety Disorders Research Program

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Neuro-Behavioral Clinical Research, Inc.

    North Canton, Ohio 44720
    United States

    Site Not Available

  • Austin Clinical Trial Partners

    Austin, Texas 78737
    United States

    Site Not Available

  • Core Clinical Research

    Everett, Washington 98201
    United States

    Site Not Available

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