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
Lighthouse Psychiatry
Gilbert, Arizona 85234
Gilbert, Arizona 85234
Scottsdale Research Institute
Scottsdale, Arizona 85022
Scottsdale, Arizona 85022
Kadima Neuropsychiatry Institute
La Jolla, California 92037
La Jolla, California 92037
UCSF Department of Neurology
San Francisco, California 94158
San Francisco, California 94158
Psychedelic Science Institute
Santa Monica, California 90404
Santa Monica, California 90404
Clinical Neuroscience Solutions Inc.
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Atlanta Center for Medical Research
Atlanta, Georgia 30331
Atlanta, Georgia 30331
CenExel iResearch, LLC
Savannah, Georgia 31405
Savannah, Georgia 31405
Uptown Research Institute
Chicago, Illinois 60640
Chicago, Illinois 60640
Adams Clinical Boston
Boston, Massachusetts 02116
Boston, Massachusetts 02116
Hassman Research Institute
Marlton, New Jersey 08053
Marlton, New Jersey 08053
Adams Clinical Harlem
New York, New York 10029
New York, New York 10029
New York State Psychiatric Institute (NYSPI)
New York, New York 10032
New York, New York 10032
Adams Clinical Bronx
The Bronx, New York 10461
The Bronx, New York 10461
Cleveland Clinic Lutheran Hospital
Cleveland, Ohio 44113
Cleveland, Ohio 44113
Summit Headlands LLC
Portland, Oregon 97210
Portland, Oregon 97210
Scranton Medical Institute
Moosic, Pennsylvania 18507
Moosic, Pennsylvania 18507
Adams Clinical Philadelphia
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Coastal Carolina Research Center
North Charleston, South Carolina 29405
North Charleston, South Carolina 29405
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee 38119
Memphis, Tennessee 38119
University of Texas at Austin
Austin, Texas 78712
Austin, Texas 78712
Adams Clinical Dallas
DeSoto, Texas 75115
DeSoto, Texas 75115
Cedar Clinical Research
Draper, Utah 84020
Draper, Utah 84020
Inner Space Research
Orem, Utah 84058
Orem, Utah 84058
Memory Clinic Inc.
Bennington, Vermont 05201
Bennington, Vermont 05201
Seattle Neuropsychiatric Treatment Center
Seattle, Washington 98104
Seattle, Washington 98104
More Details
- NCT ID
- NCT06741228
- Status
- Recruiting
- Sponsor
- Definium Therapeutics US, Inc.
Study Contact
Definium Therapeutics Clinical Trials Info Requests1-332-282-0479
clinicaltrials@definiumtx.com
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.