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)

Tonix Pharmaceuticals, Inc.27 sites in 1 country132 target enrollmentMarch 2, 2023

ConditionsDepression Depressive Disorder Depressive Symptoms Depressive Disorder, Major Depressive Episode Depression Severe

InterventionsTNX-601 ER Placebo

DrugsTNX-601 ER Placebo

Overview

Phase: Phase 2
Intervention: TNX-601 ER
Conditions: Depression
Sponsor: Tonix Pharmaceuticals, Inc.
Enrollment: 132
Locations: 27
Primary Endpoint: Montgomery Asberg Depression Rating Scale (MADRS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

March 2, 2023

End Date

September 29, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tonix Pharmaceuticals, Inc.

Responsible Party

Sponsor

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.
•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