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A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Sponsor: Tonix Pharmaceuticals, Inc.
Summary
The goal of this clinical trial is to learn if a drug called TNX-102 SL works to treat moderate to severe major depressive disorder in adults. It will also learn about the safety of TNX-102 SL. The main questions it aims to answer are: Does TNX-102 SL improve depression symptoms according to a depression symptom rating scale? What medical problems do participants have when taking TNX-102 SL? Researchers will compare TNX-102 SL to a placebo (a look-alike substance that contains no drug) to see if TNX-102 SL works to treat major depressive disorder. Participants will: Take TNX-102 SL or a placebo every night at bedtime for 6 weeks Visit the clinic once every 2 weeks for checkups and tests
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-06-25
Completion Date
2028-02
Last Updated
2026-09-25
Healthy Volunteers
No
Interventions
TNX-102 SL
Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.
Placebo sublingual tablet
Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.
Locations (27)
IMA Clinical Research- Phoenix
Phoenix, Arizona, United States
Buena Park Research Center
Buena Park, California, United States
Inland Psychiatric Medical Group, Inc. - Chino
Chino, California, United States
Synergy Research - San Diego
Lemon Grove, California, United States
Nrc Research Institute
Orange, California, United States
Artemis Institute For Clinical Research - San Diego
San Diego, California, United States
Sunwise Clinical Research, Llc
Walnut Creek, California, United States
Clinical Neuroscience Solutions Inc. - Jacksonville
Jacksonville, Florida, United States
K2 Medical Research - Maitland
Maitland, Florida, United States
Central Miami Medical Institute Llc.
Miami, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Clinical Neuroscience Solutions Inc. - Orlando
Orlando, Florida, United States
K2 Medical Research - Tampa
Tampa, Florida, United States
Evergreen Clinical Trials
Norcross, Georgia, United States
Chicago Research Center
Chicago, Illinois, United States
Delricht Research - New Orleans
New Orleans, Louisiana, United States
Delricht Research - Rockville
Rockville, Maryland, United States
Activmed Practices & Research, Llc - Methuen
Methuen, Massachusetts, United States
Redbird Research
Las Vegas, Nevada, United States
Ima Clinical Research - Nyc Midtown
New York, New York, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Clinical Neuroscience Solutions Inc. - Memphis
Mephis, Tennessee, United States
Austin Clinical Trial Partners
Austin, Texas, United States
FutureSearch Trials of Dallas
Dallas, Texas, United States
Revival Research Institute, Llc - McKinney, Tx
McKinney, Texas, United States
Delricht Research - Plano
Plano, Texas, United States
Boeson Research Pvu
Provo, Utah, United States