A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (VOYAGE)
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 - Voyage
Condition
- Generalized Anxiety Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 74 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female: must be between 18 (or the legal age of consent in the jurisdiction in which the study is taking place) and 74 years of age inclusive, at the time of signing the informed consent. 2. Diagnosis of GAD per DSM-5. 3. HAM-A Total Score ≥20.
Exclusion Criteria
- Any psychiatric disorder (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)
- Masking Description
- This study is double-blinded, which means that both the participants and the treating clinicians will be masked to treatment allocation, meaning neither party will know which participants are receiving the active drug and which are receiving the placebo. The placebo tablet is identical looking to the active drug
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Arm 1 - Placebo |
A substance that is designed to have no therapeutic value |
|
|
Experimental Arm 2 - 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
More Details
- Status
- Recruiting
- Sponsor
- Mind Medicine, Inc.
Detailed Description
The study will enroll up to 200 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 open-label extension (OLE) during which participants will be monitored and evaluated for potential retreatment with MM120 based on pre-specified safety and symptom severity criteria.
