TNX-102 SL taken at night for major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial compares TNX-102 SL, a sublingual tablet taken at bedtime, with placebo over 6 weeks in adults with a current major depressive episode. Participants visit every two weeks for safety and symptom assessments while taking the study medication or placebo. The study aims to determine whether TNX-102 SL improves depressive symptoms on a standard rating scale and to characterize any safety concerns in this population. Eligible participants have a DSM-5 diagnosis of current MDD without psychotic features and must be able to consent in English. Exclusion criteria rule out certain psychotic disorders, borderline personality disorder, and specific comorbid conditions as outlined in the protocol.

Why it matters

Who can join: the full rules

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)

Where it's running

• Clinical Research Site
  Phoenix, Arizona, United States Recruiting
• Clinical Research Site
  Buena Park, California, United States Recruiting
• Clinical Research Site
  Chino, California, United States Recruiting
• Clinical Research Site
  Lemon Grove, California, United States Recruiting
• Clinical Research Site
  Orange, California, United States Recruiting
• Clinical Research Site
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Timothy Roush
• Email: timothy.roush@tonixpharma.com
• Phone: (862) 799-8599

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.