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A Study of TNX-102 SL for Major Depressive Disorder

This study is testing a drug called TNX-102 SL to see if it can help adults with moderate to severe major depressive disorder (MDD), also known as depression. Researchers want to find out if TNX-102 SL improves depression symptoms and what side effects participants might experience. You would take either TNX-102 SL or a placebo (a pill with no active drug) every night for 6 weeks. The study is looking for 360 participants, aged 18 and older, who have been experiencing a major depressive episode for 6 weeks to 18 months, without psychotic or catatonic features. Success will be measured by changes in a depression symptom rating scale after 6 weeks. The current recruitment status is unclear.

Study design
This study compares TNX-102 SL to a placebo in 360 participants. It is an interventional study, but the phase is not specified.
What's involved
Participants will take TNX-102 SL or a placebo daily at bedtime for 6 weeks. You will also visit the clinic once every 2 weeks for checkups and tests.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 6, indicating follow-up during the 6-week treatment period.

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NCT07621237

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Tonix Pharmaceuticals, Inc.
~360 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:TNX-102 SLPlacebo sublingual tablet

At a glance

Recruiting sites
2 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline (Visit 2) in the MADRS total score at Week 6.
Measured over From Day 1 to Week 6

Conditions

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

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Where it's being run

25 sites across 14 states
Florida6
California5
Texas3
Arizona1
Georgia1
Illinois1
Louisiana1
Maryland1

Who to contact

Timothy Roush
[email protected]
(862) 799-8599
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

Diagnosis of DSM-5-defined lifetime bipolar disorder (I, II, or unspecified), schizophrenia, schizoaffective disorder, MDD with psychotic features, other psychotic disorder, or antisocial personality disorder; current (past month) obsessive-compulsive disorder; current (past month) posttraumatic stress disorder; current (past 3 months) anorexia nervosa,
Diagnosis of borderline personality disorder that is known, suspected
Participants with comorbid generalized anxiety disorder (GAD), social anxiety disorder (SAD), or panic disorder are excluded only if the GAD, SAD, or panic disorder is considered the primary psychiatric diagnosis, rather than MDD.
Participants with treatment refractory MDD, ie, previously having failed in their lifetime ≥2 treatments (due to inadequate efficacy) with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence.
History of substance use disorder and/or alcohol use disorder during the preceding 12 months
Use of antidepressants (including ketamine/esketamine, St. John's Wort, S-adenosyl methionine, and/or trazodone used as an antidepressant) within 4 weeks of Baseline (Visit 2), except for fluoxetine, which must not be within 6 weeks of Baseline (Visit 2)

What this trial measures

  • Change from Baseline (Visit 2) in the MADRS total score at Week 6.From Day 1 to 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.