Phase 2
N=132
Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)
Depression · Depressive Disorder · Depressive Symptoms · Depressive Disorder, Major · Depressive Episode
Bottom Line
View on ClinicalTrials.gov: NCT05686408 ↗Enrolled (actual)
132
Serious AEs
2.3%
Results posted
Feb 2025
Primary outcome: Primary: Montgomery Asberg Depression Rating Scale (MADRS) — -12.8; -12.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TNX-601 ER (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tonix Pharmaceuticals, Inc.
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery Asberg Depression Rating Scale (MADRS) |
-12.8; -12.7 | — |
| SECONDARY Clinical Global Impression of Severity (CGI-S) |
-1.2; -1.0 | — |
| SECONDARY Sheehan Disability Scale (SDS) |
-7.3; -5.8 | — |
Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy versus placebo in patients with Major Depressive Disorder (MDD).
Eligibility Criteria
Inclusion Criteria
- Female or male aged 18 to 65 years (inclusive).
- Have a primary DSM-5 diagnosis of current MDD.
- The duration of the current MDE must be at least 12 weeks.
- Without psychotic or catatonic features.
Exclusion Criteria
- Psychiatric History:
- 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; lifetime opioid or lifetime sedative-hypnotic use disorders, as confirmed by the MINI 7.0.2.
- Diagnosis of borderline personality disorder
- Patients 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. (If MDD is the primary diagnosis, patients with comorbid GAD, SAD, and panic disorder are allowed for randomization).
- Patients with treatment refractory MDD, ie, previously having in their lifetime failed ≥2 treatments with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence
Data sourced from ClinicalTrials.gov (NCT05686408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.