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 5295903, Arizona 5551752 85234
Gilbert 5295903, Arizona 5551752 85234
Scottsdale Research Institute
Scottsdale 5313457, Arizona 5551752 85022
Scottsdale 5313457, Arizona 5551752 85022
Kadima Neuropsychiatry Institute
La Jolla 5363943, California 5332921 92037
La Jolla 5363943, California 5332921 92037
UCSF Department of Neurology
San Francisco 5391959, California 5332921 94158
San Francisco 5391959, California 5332921 94158
Psychedelic Science Institute
Santa Monica 5393212, California 5332921 90404
Santa Monica 5393212, California 5332921 90404
Mountain View
Denver 5419384, Colorado 5417618 80209
Denver 5419384, Colorado 5417618 80209
Clinical Neuroscience Solutions Inc.
Jacksonville 4160021, Florida 4155751 32256
Jacksonville 4160021, Florida 4155751 32256
Atlanta Center for Medical Research
Atlanta 4180439, Georgia 4197000 30331
Atlanta 4180439, Georgia 4197000 30331
iResearch Atlanta
Decatur 4191124, Georgia 4197000 30030
Decatur 4191124, Georgia 4197000 30030
CenExel iResearch, LLC
Savannah 4221552, Georgia 4197000 31405
Savannah 4221552, Georgia 4197000 31405
Uptown Research Institute
Chicago 4887398, Illinois 4896861 60640
Chicago 4887398, Illinois 4896861 60640
Adams Clinical Boston
Boston 4930956, Massachusetts 6254926 02116
Boston 4930956, Massachusetts 6254926 02116
Hassman Research Institute
Marlton 4502911, New Jersey 5101760 08053
Marlton 4502911, New Jersey 5101760 08053
Adams Clinical Harlem
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10029
Adams Clinical Bronx
The Bronx 5110266, New York 5128638 10461
The Bronx 5110266, New York 5128638 10461
Cleveland Clinic Lutheran Hospital
Cleveland 5150529, Ohio 5165418 44113
Cleveland 5150529, Ohio 5165418 44113
Summit Headlands LLC
Portland 5746545, Oregon 5744337 97210
Portland 5746545, Oregon 5744337 97210
Scranton Medical Institute
Moosic 5201901, Pennsylvania 6254927 18507
Moosic 5201901, Pennsylvania 6254927 18507
Adams Clinical Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Coastal Carolina Research Center
North Charleston 4589387, South Carolina 4597040 29405
North Charleston 4589387, South Carolina 4597040 29405
Clinical Neuroscience Solutions, Inc.
Memphis 4641239, Tennessee 4662168 38119
Memphis 4641239, Tennessee 4662168 38119
University of Texas at Austin
Austin 4671654, Texas 4736286 78712
Austin 4671654, Texas 4736286 78712
FutureSearch Trials of Dallas, LLC
Dallas 4684888, Texas 4736286 75231
Dallas 4684888, Texas 4736286 75231
Adams Clinical Dallas
DeSoto 4685524, Texas 4736286 75115
DeSoto 4685524, Texas 4736286 75115
Cedar Clinical Research
Draper 5774001, Utah 5549030 84020
Draper 5774001, Utah 5549030 84020
Inner Space Research
Orem 5779334, Utah 5549030 84058
Orem 5779334, Utah 5549030 84058
Memory Clinic Inc.
Bennington 5233742, Vermont 5242283 05201
Bennington 5233742, Vermont 5242283 05201
Seattle Neuropsychiatric Treatment Center
Seattle 5809844, Washington 5815135 98104
Seattle 5809844, Washington 5815135 98104
More Details
- NCT ID
- NCT06741228
- Status
- Recruiting
- Sponsor
- Definium Therapeutics
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.