Evaluating MM120 for Generalized Anxiety Disorder

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

This study is testing if a new treatment called MM120 can help people with Generalized Anxiety Disorder feel better compared to a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: Mind Medicine, Inc. (industry)
• Locations: 15 sites (Little Rock, Arkansas and 14 other locations)
• Trial ID: NCT06809595 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial aims to assess the efficacy of MM120, a compound derived from LSD, in treating Generalized Anxiety Disorder (GAD) compared to a placebo. The study will enroll up to 375 participants aged 18 to 74 who have a confirmed diagnosis of GAD and meet specific severity criteria. Participants will undergo a 12-week randomized, double-blind period followed by a 40-week open-label extension phase, where they will be monitored for safety and symptom improvement. The trial seeks to provide insights into the potential benefits of MM120 for individuals suffering from GAD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 74 with a confirmed diagnosis of Generalized Anxiety Disorder and a minimum HAM-A score of 20.

Not a fit: Patients with other significant psychiatric disorders or unstable medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate symptoms of Generalized Anxiety Disorder for many patients.

How similar studies have performed: Previous studies exploring the therapeutic potential of psychedelics for anxiety have shown promising results, suggesting a potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Little Rock, Arkansas and 14 other locations

• Preferred Research Partners, Inc. — Little Rock, Arkansas, United States (RECRUITING)
• New School Research — Los Angeles, California, United States (NOT_YET_RECRUITING)
• West Los Angeles VA Medical Center — Los Angeles, California, United States (NOT_YET_RECRUITING)
• Cenexel-CNS — Torrance, California, United States (RECRUITING)
• Bradenton Research Center, Inc. — Bradenton, Florida, United States (RECRUITING)
• Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States (RECRUITING)
• Atlanta Center for Medical Research — Atlanta, Georgia, United States (RECRUITING)
• Sheppard Pratt Health System — Towson, Maryland, United States (RECRUITING)
• Copley Clinical — Boston, Massachusetts, United States (RECRUITING)
• Princeton Medical Institute — Princeton, New Jersey, United States (RECRUITING)
• University of Cincinnati Psychiatry- Anxiety Disorders Research Program — Cincinnati, Ohio, United States (RECRUITING)
• Neuro-Behavioral Clinical Research, Inc. — North Canton, Ohio, United States (RECRUITING)
• Austin Clinical Trial Partners — Austin, Texas, United States (RECRUITING)
• Cedar Clinical Research — Murray, Utah, United States (RECRUITING)
• Core Clinical Research — Everett, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Mind Medicine, Inc. Clinical Trials Info Requests

Conditions: Generalized Anxiety Disorder