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A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)

NCT07621237

This study is recruiting at 25 US sites in 12 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Major Depressive Episode (MDE)
  • Major Depressive Disorder (MDD)
  • Depression

Eligibility basics and study details

Study type
Interventional
Phase
Phase 2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Tonix Pharmaceuticals, Inc.
Last updated on ClinicalTrials.gov
September 25, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Arizona · 1

  • IMA Clinical Research- Phoenix · Phoenix, AZ

California · 6

  • Buena Park Research Center · Buena Park, CA
  • Inland Psychiatric Medical Group, Inc. - Chino · Chino, CA
  • Synergy Research - San Diego · Lemon Grove, CA
  • Nrc Research Institute · Orange, CA
  • Artemis Institute For Clinical Research - San Diego · San Diego, CA
  • Sunwise Clinical Research, Llc · Walnut Creek, CA

Florida · 6

  • Clinical Neuroscience Solutions Inc. - Jacksonville · Jacksonville, FL
  • K2 Medical Research - Maitland · Maitland, FL
  • Central Miami Medical Institute Llc. · Miami, FL
  • Medical Research Group of Central Florida · Orange City, FL
  • Clinical Neuroscience Solutions Inc. - Orlando · Orlando, FL
  • K2 Medical Research - Tampa · Tampa, FL

Georgia · 1

  • Evergreen Clinical Trials · Norcross, GA

Illinois · 1

  • Chicago Research Center · Chicago, IL

Maryland · 1

  • Delricht Research - Rockville · Rockville, MD

Massachusetts · 1

  • Activmed Practices & Research, Llc - Methuen · Methuen, MA

Nevada · 1

  • Redbird Research · Las Vegas, NV

New York · 1

  • Ima Clinical Research - Nyc Midtown · New York, NY

South Carolina · 1

  • Coastal Carolina Research Center · North Charleston, SC

Texas · 4

  • Austin Clinical Trial Partners · Austin, TX
  • FutureSearch Trials of Dallas · Dallas, TX
  • Revival Research Institute, Llc - McKinney, Tx · McKinney, TX
  • Delricht Research - Plano · Plano, TX

Utah · 1

  • Boeson Research Pvu · Provo, UT

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.