RecruitingPhase 3NCT06809595

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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40 Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults With Generalized Anxiety Disorder - Panorama


Sponsor

Definium Therapeutics US, Inc.

Enrollment

250 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 74 Years

Inclusion Criteria3

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

Exclusion Criteria4

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

Interventions

OTHERPlacebo

A substance that is designed to have no therapeutic value

DRUGMM120 (LSD D-Tartrate)

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


Locations(38)

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

Hôpital Conception, CIC Centre, bat néphrologie 3eme étage

Marseille, 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

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

Lodz, 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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NCT06809595


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