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

NCT07621237 | Recruiting Phase 2 FDA Drug

• 1 other identifier: TNX-CY-MD201
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 25

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

Keywords

Depression; TNX-102 SL; Cyclobenzaprine

Outcome Measures

Primary Outcomes (1)

• 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.

  From Day 1 to Week 6

Secondary Outcomes (4)

• Change from Baseline (Visit 2) in the Clinician Global Impression - Severity (CGI-S) score at Week 6

  From Day 1 to Week 6

• Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6

  From Day 1 to Week 6

• Change from Baseline (Visit 2) in the MADRS total score at Week 4.

  From Day 1 to Week 4

• Change from Baseline (Visit 2) in the MADRS total score at Week 2.

  From Day 1 to Week 2

Study Arms (2)

TNX-102 SL

EXPERIMENTAL

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

Placebo sublingual tablets

PLACEBO COMPARATOR

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

Drug: Placebo sublingual tablet

Interventions

TNX-102 SL DRUG

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

TNX-102 SL

Placebo sublingual tablet DRUG

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

Placebo sublingual tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead

Study Sites (25)

IMA Clinical Research- Phoenix

Phoenix, Arizona, 85012, United States

NOT YET RECRUITING

Inland Psychiatric Medical Group, Inc. - Chino

Chino, California, 91710, United States

NOT YET RECRUITING

Synergy Research - San Diego

Lemon Grove, California, 91945, United States

NOT YET RECRUITING

Nrc Research Institute

Orange, California, 92868, United States

NOT YET RECRUITING

Artemis Institute For Clinical Research - San Diego

San Diego, California, 92123, United States

NOT YET RECRUITING

Sunwise Clinical Research, Llc

Walnut Creek, California, 94596, United States

NOT YET RECRUITING

Clinical Neuroscience Solutions Inc. - Jacksonville

Jacksonville, Florida, 32256, United States

NOT YET RECRUITING

K2 Medical Research - Maitland

Maitland, Florida, 32751, United States

NOT YET RECRUITING

Central Miami Medical Institute Llc.

Miami, Florida, 33125, United States

NOT YET RECRUITING

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

NOT YET RECRUITING

Clinical Neuroscience Solutions Inc. - Orlando

Orlando, Florida, 32801, United States

RECRUITING

K2 Medical Research - Tampa

Tampa, Florida, 33634, United States

NOT YET RECRUITING

Evergreen Clinical Trials

Norcross, Georgia, 30092, United States

NOT YET RECRUITING

Chicago Research Center

Chicago, Illinois, 60634, United States

NOT YET RECRUITING

Delricht Research - New Orleans

New Orleans, Louisiana, 70115, United States

RECRUITING

Delricht Research - Rockville

Rockville, Maryland, 20852, United States

NOT YET RECRUITING

Activmed Practices & Research, Llc - Methuen

Methuen, Massachusetts, 01844, United States

NOT YET RECRUITING

Redbird Research

Las Vegas, Nevada, 89119, United States

NOT YET RECRUITING

Ima Clinical Research - Nyc Midtown

New York, New York, 10036, United States

NOT YET RECRUITING

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

NOT YET RECRUITING

Clinical Neuroscience Solutions Inc. - Memphis

Mephis, Tennessee, 38119, United States

NOT YET RECRUITING

Austin Clinical Trial Partners

Austin, Texas, 78737, United States

NOT YET RECRUITING

Revival Research Institute, Llc - McKinney, Tx

McKinney, Texas, 75071, United States

NOT YET RECRUITING

Delricht Research - Plano

Plano, Texas, 75024, United States

NOT YET RECRUITING

Boeson Research Pvu

Provo, Utah, 84604, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

cyclobenzaprine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Timothy Roush

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-06

Locations

US (25)