A Phase 2 interventional study of TNX-102 SL and Placebo sublingual tablet in Major Depressive Episode (MDE), Major Depressive Disorder (MDD) and Depression, sponsored by Tonix Pharmaceuticals, Inc.. Recruiting at 27 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Tonix Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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
Exclusion Criteria:
Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.
Drug: TNX-102 SL
Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.
Drug: Placebo sublingual tablet
Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.
Also known as: cyclobenzaprine, cyclobenzaprine HCl
Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.
Change from Baseline (Visit 2) in the MADRS total score at Week 6.
Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
Time frame: From Day 1 to Week 6
Change from Baseline (Visit 2) in the Clinician Global Impression - Severity (CGI-S) score at Week 6
Change from Baseline (Visit 2) in the Clinical Global Impression of Severity Scale (CGI-S) score at Week 6. Scores range from 1 to 5. Lower scores indicate less severe illness.
Time frame: From Day 1 to Week 6
Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6
Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6. The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).
Time frame: From Day 1 to Week 6
Change from Baseline (Visit 2) in the MADRS total score at Week 4.
Change from Baseline (Visit 2) in the MADRS total score at Week 4. Scores range from 0 to 60. Lower scores indicate less depression.
Time frame: From Day 1 to Week 4
Change from Baseline (Visit 2) in the MADRS total score at Week 2.
Change from Baseline (Visit 2) in the MADRS total score at Week 2. Scores range from 0 to 60. Lower scores indicate less depression.
Time frame: From Day 1 to Week 2
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Tonix Pharmaceuticals, Inc.