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

Generalized Anxiety Disorder

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

Plain Language Summary

Simplified for easier understanding

This Phase 3 trial is testing MM120 — a form of LSD at a specific, carefully controlled dose — as a treatment for generalized anxiety disorder (GAD). GAD is a condition involving persistent, hard-to-control worry about many areas of life. This trial builds on earlier results suggesting a single dose may provide sustained anxiety relief. **You may be eligible if...** - You have been diagnosed with generalized anxiety disorder - You are an adult meeting the study's age requirements - Your anxiety has not been adequately controlled by current treatments - You are willing to participate in a supervised dosing session **You may NOT be eligible if...** - You have a personal or family history of psychosis or schizophrenia - You have certain heart conditions or take medications that interact with MM120 - You are currently using psychedelic substances or are at high risk of substance misuse - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06809595

Related Trials

Stepped Versus Stratified Care for Anxiety Disorders in Youth

NCT069424291 location

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

NCT0674122836 locations

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

NCT066614601 location

CO2 Reactivity as a Biomarker of Non-Response to Exposure-Based Therapy

NCT054676832 locations

Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness

NCT063767342 locations