A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)
Purpose
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
Condition
- Generalized Anxiety Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 74 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of GAD per DSM-5 2. Male or female aged 18 to 74 3. HAM-A Total Score ≥20
Exclusion Criteria
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Arm 1 - Placebo |
A substance that is designed to have no therapeutic value |
|
|
Sham Comparator 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) |
|
|
Experimental 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) |
|
Recruiting Locations
Little Rock, Arkansas 72211
Bradenton, Florida 34205
Orlando, Florida 32801
Atlanta, Georgia 30331
Towson, Maryland 21204
Boston, Massachusetts 02116
Princeton, New Jersey 08540
Cincinnati, Ohio 45219
North Canton, Ohio 44720
Austin, Texas 78737
Murray, Utah 84107
Everett, Washington 98201
More Details
- NCT ID
- NCT06809595
- Status
- Recruiting
- Sponsor
- Mind Medicine, Inc.
Study Contact
Mind Medicine, Inc. Clinical Trials Info Requests1-332-282-0479
ClinicalTrials@Mindmed.co
Detailed Description
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.