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 Sex
- 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)
- 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
Gilbert 5295903, Arizona 5551752 85234
La Jolla 5363943, California 5332921 92037
San Francisco 5391959, California 5332921 94158
Denver 5419384, Colorado 5417618 80209
Jacksonville 4160021, Florida 4155751 32256
Lakeland 4161438, Florida 4155751 33803
Decatur 4191124, Georgia 4197000 30030
Savannah 4221552, Georgia 4197000 31405
Chicago 4887398, Illinois 4896861 60640
Boston 4930956, Massachusetts 6254926 02116
Watertown 4954611, Massachusetts 6254926 02472
Columbia 4381982, Missouri 4398678 65212
Marlton 4502911, New Jersey 5101760 08053
New York 5128581, New York 5128638 10021
Cleveland 5150529, Ohio 5165418 44113
Portland 5746545, Oregon 5744337 97210
Philadelphia 4560349, Pennsylvania 6254927 19104
North Charleston 4589387, South Carolina 4597040 29405
Memphis 4641239, Tennessee 4662168 38119
Austin 4671654, Texas 4736286 78712
Draper 5774001, Utah 5549030 84020
Bennington 5233742, Vermont 5242283 05201
Seattle 5809844, Washington 5815135 98104
More Details
- NCT ID
- NCT06741228
- 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 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.