Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 30, 2026
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Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07621237). This is a study registration, not published results. Lead sponsor: Tonix Pharmaceuticals, Inc.. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 360 participants (ESTIMATED). Conditions: Major Depressive Episode (MDE), Major Depressive Disorder (MDD), Depression. Interventions: DRUG: TNX-102 SL; DRUG: Placebo sublingual tablet. Primary outcome measures: Change from Baseline (Visit 2) in the MADRS total score at Week 6. , From Day 1 to Week 6. Brief 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