NCT07621237From ClinicalTrials.govRecruiting

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)

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

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Tonix Pharmaceuticals, Inc.
Enrolment target: 360
Started: 25 June 2026
Main results due: February 2028
Study sites: 27
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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 study is about

In the sponsor’s own words, from the registry.

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

Study sites(27)

IMA Clinical Research- Phoenix
Phoenix, Arizona, United States
Recruiting
Buena Park Research Center
Buena Park, California, United States
Recruiting
Inland Psychiatric Medical Group, Inc. - Chino
Chino, California, United States
Recruiting
Synergy Research - San Diego
Lemon Grove, California, United States
Recruiting
Nrc Research Institute
Orange, California, United States
Recruiting
Artemis Institute For Clinical Research - San Diego
San Diego, California, United States
Recruiting
Sunwise Clinical Research, Llc
Walnut Creek, California, United States
Recruiting
Clinical Neuroscience Solutions Inc. - Jacksonville
Jacksonville, Florida, United States
Recruiting
K2 Medical Research - Maitland
Maitland, Florida, United States
Recruiting
Central Miami Medical Institute Llc.
Miami, Florida, United States
Recruiting
Medical Research Group of Central Florida
Orange City, Florida, United States
Recruiting
Clinical Neuroscience Solutions Inc. - Orlando
Orlando, Florida, United States
Recruiting
K2 Medical Research - Tampa
Tampa, Florida, United States
Recruiting
Evergreen Clinical Trials
Norcross, Georgia, United States
Recruiting
Chicago Research Center
Chicago, Illinois, United States
Recruiting
Delricht Research - New Orleans
New Orleans, Louisiana, United States
Withdrawn
Delricht Research - Rockville
Rockville, Maryland, United States
Recruiting
Activmed Practices & Research, Llc - Methuen
Methuen, Massachusetts, United States
Recruiting
Redbird Research
Las Vegas, Nevada, United States
Recruiting
Ima Clinical Research - Nyc Midtown
New York, New York, United States
Recruiting
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Recruiting
Clinical Neuroscience Solutions Inc. - Memphis
Mephis, Tennessee, United States
Recruiting
Austin Clinical Trial Partners
Austin, Texas, United States
Recruiting
FutureSearch Trials of Dallas
Dallas, Texas, United States
Recruiting
Revival Research Institute, Llc - McKinney, Tx
McKinney, Texas, United States
Recruiting
Delricht Research - Plano
Plano, Texas, United States
Recruiting
Boeson Research Pvu
Provo, Utah, United States
Recruiting

Showing 27 of 27 sites. 26 of the 27 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07621237. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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