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

NCT ID: NCT06809595

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-29

Study Completion Date

2027-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 MM120 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 MM120 based on pre-specified safety and symptom severity criteria.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Generalized Anxiety Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1 - Placebo

A substance that is designed to have no therapeutic value

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

A substance that is designed to have no therapeutic value

Arm 2 - 50µg MM120 (LSD D-Tartrate)

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

Group Type SHAM_COMPARATOR

MM120 (LSD D-Tartrate)

Intervention Type DRUG

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

Arm 3 - 100µg MM120 (LSD D-Tartrate)

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

Group Type EXPERIMENTAL

MM120 (LSD D-Tartrate)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

A substance that is designed to have no therapeutic value

Intervention Type OTHER

MM120 (LSD D-Tartrate)

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mind Medicine, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

Site Status RECRUITING

Psychedelic Science Institute

Los Angeles, California, United States

Site Status RECRUITING

West Los Angeles VA Medical Center

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

Cenexel-CNS

Torrance, California, United States

Site Status ACTIVE_NOT_RECRUITING

Bradenton Research Center, Inc.

Bradenton, Florida, United States

Site Status RECRUITING

Clinical Neuroscience Solutions, Inc

Orlando, Florida, United States

Site Status RECRUITING

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Sheppard Pratt Health System

Towson, Maryland, United States

Site Status RECRUITING

Adams Clinical Boston

Boston, Massachusetts, United States

Site Status ACTIVE_NOT_RECRUITING

Princeton Medical Institute

Princeton, New Jersey, United States

Site Status RECRUITING

University of Cincinnati Psychiatry- Anxiety Disorders Research Program

Cincinnati, Ohio, United States

Site Status RECRUITING

Neuro-Behavioral Clinical Research, Inc.

North Canton, Ohio, United States

Site Status RECRUITING

Austin Clinical Trial Partners

Austin, Texas, United States

Site Status RECRUITING

Cedar Clinical Research

Murray, Utah, United States

Site Status RECRUITING

Core Clinical Research

Everett, Washington, United States

Site Status RECRUITING

A-shine s.r.o.

Pilsen, , Czechia

Site Status RECRUITING

Institut Neuropsychiatricke Pece (INEP)

Prague, , Czechia

Site Status RECRUITING

Psyon s.r.o.

Prague, , Czechia

Site Status RECRUITING

CMME

Paris, , France

Site Status RECRUITING

GHU Paris Psychiatrie et Neurosciences

Paris, , France

Site Status RECRUITING

Department of Psychiatry and Psychotherapy Campus Charité Mitte Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

OVID Clinic Berlin

Berlin, , Germany

Site Status RECRUITING

Central Institute of Mental Health

Mannheim, , Germany

Site Status RECRUITING

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

Tübingen, , Germany

Site Status RECRUITING

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

Gdansk, , Poland

Site Status RECRUITING

Department of Psychiatry, UCK

Gdansk, , Poland

Site Status RECRUITING

Clerkenwell Health - Baker Street

London, , United Kingdom

Site Status RECRUITING

Clerkenwell Health

London, , United Kingdom

Site Status RECRUITING

South London and Maudsley NHS Foundation Trust of The Maudsley Hospital

London, , United Kingdom

Site Status RECRUITING

4 Medical Clinical Solutions

Manchester, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Czechia France Germany Poland United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mind Medicine, Inc. Clinical Trials Info Requests

Role: CONTACT

Phone: 1-332-282-0479

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Stacy Tierney

Role: primary

Keith Heinzerling

Role: primary

Walter Dunn, MD, PhD

Role: primary

Eric Folkens

Role: primary

Chanel Adams

Role: primary

Audrey Shoultz

Role: primary

Adria Trapani-Barnacz, APN

Role: primary

Heidi K Schroeder

Role: primary

Regina Leising

Role: primary

Cara Fonken

Role: primary

Janet Jimenez

Role: primary

Maria Golescu

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MM120-301

Identifier Type: -

Identifier Source: org_study_id