A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Key facts
- Where
- Austin, Buena Park, Chicago, Chino, Dallas, Jacksonville, Las Vegas, Lemon Grove, Maitland, McKinney, Mephis, Methuen, Miami, New Orleans, New York, Norcross, North Charleston, Orange, Orange City, Orlando, Phoenix, Plano, Provo, Rockville, San Diego, Tampa, and Walnut Creek, United StatesSee the 27 sites
- Phase
- Phase 2
Where in United States
- AustinAustin, United StatesTaking people
- Buena ParkBuena Park, United StatesTaking people
- ChicagoChicago, United StatesTaking people
- ChinoChino, United StatesTaking people
- DallasDallas, United StatesTaking people
- JacksonvilleJacksonville, United StatesTaking people
- Las VegasLas Vegas, United StatesTaking people
- Lemon GroveLemon Grove, United StatesTaking people
- MaitlandMaitland, United StatesTaking people
- McKinneyMcKinney, United StatesTaking people
- MephisMephis, United StatesTaking people
- MethuenMethuen, United StatesTaking people
- MiamiMiami, United StatesTaking people
- New OrleansNew Orleans, United StatesNo longer taking part
- New YorkNew York, United StatesTaking people
- NorcrossNorcross, United StatesTaking people
- North CharlestonNorth Charleston, United StatesTaking people
- OrangeOrange, United StatesTaking people
- Orange CityOrange City, United StatesTaking people
- OrlandoOrlando, United StatesTaking people
- PhoenixPhoenix, United StatesTaking people
- PlanoPlano, United StatesTaking people
- ProvoProvo, United StatesTaking people
- RockvilleRockville, United StatesTaking people
- San DiegoSan Diego, United StatesTaking people
- TampaTampa, United StatesTaking people
- Walnut CreekWalnut Creek, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tonix Pharmaceuticals, Inc.
- Trial code
- NCT07621237
- Record updated
- 30 October 2026
- Original description
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:Read full original descriptionShow less
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)
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
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: 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; 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; 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).