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 - Voyage
This study is testing a new treatment called MM120 to see if it can help people with Generalized Anxiety Disorder feel better compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Mind Medicine, Inc. Industry-sponsored |
| Locations | 29 sites (Gilbert, Arizona and 28 other locations) |
| Trial ID | NCT06741228 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical 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 200 participants aged 18 to 74 who have a confirmed diagnosis of GAD and meet specific severity criteria. Participants will undergo a 12-week double-blind period followed by a 40-week open-label extension, 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 offer a novel therapeutic option for patients with Generalized Anxiety Disorder.
How similar studies have performed: While studies on psychedelics for anxiety are emerging, this specific approach with MM120 is relatively novel and has not been extensively tested in prior trials.
Eligibility criteria
Show full inclusion / exclusion 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
Gilbert, Arizona and 28 other locations
- Lighthouse Psychiatry — Gilbert, Arizona, United States (Recruiting)
- Kadima Neuropsychiatry Institute — La Jolla, California, United States (Recruiting)
- UCSF Department of Neurology — San Francisco, California, United States (Not_yet_recruiting)
- Pacific Neuroscience Institute — Santa Monica, California, United States (Not_yet_recruiting)
- Mountain View — Denver, Colorado, United States (Recruiting)
- Clinical Neuroscience Solutions Inc. — Jacksonville, Florida, United States (Recruiting)
- Accel Research Sites - Lakeland CRU — Lakeland, Florida, United States (Recruiting)
- Segal Trials — Lauderhill, Florida, United States (Recruiting)
- Atlanta Center for Medical Research — Atlanta, Georgia, United States (Not_yet_recruiting)
- iResearch Atlanta — Decatur, Georgia, United States (Recruiting)
- CenExel iResearch, LLC — Savannah, Georgia, United States (Not_yet_recruiting)
- Uptown Research Institute — Chicago, Illinois, United States (Recruiting)
- Copley Clinical — Boston, Massachusetts, United States (Not_yet_recruiting)
- Adams Clinical — Watertown, Massachusetts, United States (Recruiting)
- University of Missouri Health Care — Columbia, Missouri, United States (Recruiting)
- Hassman Research Institute — Marlton, New Jersey, United States (Not_yet_recruiting)
- Spectrum Neuroscience and Treatment Institute — New York, New York, United States (Not_yet_recruiting)
- New York State Psychiatric Institute (NYSPI) — New York, New York, United States (Not_yet_recruiting)
- Cleveland Clinic Lutheran Hospital — Cleveland, Ohio, United States (Not_yet_recruiting)
- Summit Headlands LLC — Portland, Oregon, United States (Recruiting)
- Scranton Medical Institute — Moosic, Pennsylvania, United States (Recruiting)
- Coastal Carolina Research Center — North Charleston, South Carolina, United States (Recruiting)
- Clinical Neuroscience Solutions, Inc. — Memphis, Tennessee, United States (Recruiting)
- Dell Medical School, University of Texas at Austin — Austin, Texas, United States (Recruiting)
- Austin Clinical Trial Partners — Austin, Texas, United States (Not_yet_recruiting)
- BioBehavioral Research of Austin — Austin, Texas, United States (Active_not_recruiting)
- Cedar Clinical Research — Draper, Utah, United States (Recruiting)
- Memory Clinic Inc. — Bennington, Vermont, United States (Recruiting)
- Seattle Neuropsychiatric Treatment Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Mind Medicine Clinical Trials Info Requests
- Email: clinicaltrials@mindmed.co
- Phone: 332-282-0479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.