Recruiting

Phase 2

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

Sponsor:

Tonix Pharmaceuticals, Inc.

Code:

NCT07621237

Conditions

Major Depressive Episode (MDE)

Major Depressive Disorder (MDD)

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TNX-102 SL

Placebo sublingual tablet

Study Details

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

Conditions

Major Depressive Episode (MDE)

Major Depressive Disorder (MDD)

Depression

Study ID

NCT07621237

Start date

Jun 25, 2026

Status verified date

Sep, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TNX-102 SL

Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.

placebo comparator: Placebo sublingual tablets

Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.

Interventions

TNX-102 SL

Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.

Placebo sublingual tablet

Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.

Primary outcome measure

Change from Baseline (Visit 2) in the MADRS total score at Week 6. [ Time Frame: From Day 1 to Week 6 ]

Central Contacts and Locations

Central contacts

Timothy Roush

(862) 799-8599 timothy.roush@tonixpharma.com

Locations

IMA Clinical Research- Phoenix

Recruiting

Phoenix, Arizona, United States, 85012

Buena Park Research Center

Recruiting

Buena Park, California, United States, 90620

Inland Psychiatric Medical Group, Inc. - Chino

Recruiting

Chino, California, United States, 91710

Synergy Research - San Diego

Recruiting

Lemon Grove, California, United States, 91945

Nrc Research Institute

Recruiting

Orange, California, United States, 92868

Artemis Institute For Clinical Research - San Diego

Recruiting

San Diego, California, United States, 92123

Sunwise Clinical Research, Llc

Recruiting

Walnut Creek, California, United States, 94596

Clinical Neuroscience Solutions Inc. - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32256

K2 Medical Research - Maitland

Recruiting

Maitland, Florida, United States, 32751

Central Miami Medical Institute Llc.

Recruiting

Miami, Florida, United States, 33125

Medical Research Group of Central Florida

Recruiting

Orange City, Florida, United States, 32763

Clinical Neuroscience Solutions Inc. - Orlando

Recruiting

Orlando, Florida, United States, 32801

K2 Medical Research - Tampa

Recruiting

Tampa, Florida, United States, 33634

Evergreen Clinical Trials

Recruiting

Norcross, Georgia, United States, 30092

Chicago Research Center

Recruiting

Chicago, Illinois, United States, 60634

Delricht Research - Rockville

Recruiting

Rockville, Maryland, United States, 20852

Activmed Practices & Research, Llc - Methuen

Recruiting

Methuen, Massachusetts, United States, 01844

Redbird Research

Recruiting

Las Vegas, Nevada, United States, 89119

Ima Clinical Research - Nyc Midtown

Recruiting

New York, New York, United States, 10036

Coastal Carolina Research Center

Recruiting

North Charleston, South Carolina, United States, 29405

Clinical Neuroscience Solutions Inc. - Memphis

Recruiting

Mephis, Tennessee, United States, 38119

Austin Clinical Trial Partners

Recruiting

Austin, Texas, United States, 78737

FutureSearch Trials of Dallas

Recruiting

Dallas, Texas, United States, 75251

Revival Research Institute, Llc - McKinney, Tx

Recruiting

McKinney, Texas, United States, 75071

Delricht Research - Plano

Recruiting

Plano, Texas, United States, 75024

Boeson Research Pvu

Recruiting

Provo, Utah, United States, 84604

More Information

Sponsor

Tonix Pharmaceuticals, Inc.

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

Depression
TNX-102 SL
Cyclobenzaprine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Tonix Pharmaceuticals, Inc. on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.