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)
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Primary DSM-5 diagnosis of current MDD.
• The duration of the current MDE must be between 6 weeks and 18 months.
• Without psychotic or catatonic features.
• Capable of reading and understanding English and able to provide written informed consent to participate.
Locations
United States
Arizona
IMA Clinical Research- Phoenix
NOT_YET_RECRUITING
Phoenix
California
Inland Psychiatric Medical Group, Inc. - Chino
NOT_YET_RECRUITING
Chino
Synergy Research - San Diego
NOT_YET_RECRUITING
Lemon Grove
Nrc Research Institute
NOT_YET_RECRUITING
Orange
Artemis Institute For Clinical Research - San Diego
NOT_YET_RECRUITING
San Diego
Sunwise Clinical Research, Llc
NOT_YET_RECRUITING
Walnut Creek
Florida
Clinical Neuroscience Solutions Inc. - Jacksonville
NOT_YET_RECRUITING
Jacksonville
K2 Medical Research - Maitland
NOT_YET_RECRUITING
Maitland
Central Miami Medical Institute Llc.
NOT_YET_RECRUITING
Miami
Medical Research Group of Central Florida
NOT_YET_RECRUITING
Orange City
Clinical Neuroscience Solutions Inc. - Orlando
RECRUITING
Orlando
K2 Medical Research - Tampa
NOT_YET_RECRUITING
Tampa
Georgia
Evergreen Clinical Trials
NOT_YET_RECRUITING
Norcross
Illinois
Chicago Research Center
NOT_YET_RECRUITING
Chicago
Louisiana
Delricht Research - New Orleans
RECRUITING
New Orleans
Massachusetts
Activmed Practices & Research, Llc - Methuen
NOT_YET_RECRUITING
Methuen
Maryland
Delricht Research - Rockville
NOT_YET_RECRUITING
Rockville
Nevada
Redbird Research
NOT_YET_RECRUITING
Las Vegas
New York
Ima Clinical Research - Nyc Midtown
NOT_YET_RECRUITING
New York
South Carolina
Coastal Carolina Research Center
NOT_YET_RECRUITING
North Charleston
Tennessee
Clinical Neuroscience Solutions Inc. - Memphis
NOT_YET_RECRUITING
Mephis
Texas
Austin Clinical Trial Partners
NOT_YET_RECRUITING
Austin
Revival Research Institute, Llc - McKinney, Tx
NOT_YET_RECRUITING
Mckinney
Delricht Research - Plano
NOT_YET_RECRUITING
Plano
Utah
Boeson Research Pvu
NOT_YET_RECRUITING
Provo
Contact Information
Primary
Timothy Roush
timothy.roush@tonixpharma.com
(862) 799-8599
Time Frame
Start Date:2026-06
Estimated Completion Date:2028-02
Participants
Target number of participants:360
Treatments
Experimental: 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_comparator: Placebo sublingual tablets
Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.