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 2026-10-30.
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
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 360 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Tonix Pharmaceuticals, Inc. is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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Started Jun 2026 (actual). Primary completion is estimated for Feb 2028, 20 months after the start.
Of 96 industry-sponsored phase 2 interventional studies under Depressive Disorder, Major, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 23. This study's planned 20 months is above that.
Counting every sponsor, half of 195 studies reached it within 22 months; a quarter within 14 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Cyclobenzaprine