Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)

Phase 2

Completed

• Conditions: Depressive Disorder, Major; Depressive Episode; Depression Severe; Depression; Depressive Disorder; Depressive Symptoms
• Interventions: Drug: Placebo; Drug: TNX-601 ER

• Registration Number: NCT05686408
• Lead Sponsor: Tonix Pharmaceuticals, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-06
• Study First Posted: 2023-01-17
• Study Start: 2023-03-02
• Primary Completion: 2023-09-29
• Study Completion: 2023-09-29
• Status Verified: 2025-01
• Results First Submitted: 2025-01-24
• Results First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Results First Posted: 2025-02-17
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Female or male aged 18 to 65 years (inclusive).

• Have a primary DSM-5 diagnosis of current MDD.

  1. The duration of the current MDE must be at least 12 weeks.
  2. Without psychotic or catatonic features.

Exclusion Criteria

• Psychiatric History:

  1. 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.
  2. Diagnosis of borderline personality disorder
  3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablet taken orally once daily for 6 weeks.
TNX-601 ER, 39.4 mg	TNX-601 ER	1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale (MADRS)	Day 1 and 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.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression of Severity (CGI-S)	Day 1 and Week 6	Change from Baseline (Visit 2) in the Clinical Global Impression of Severity Scale (CGI-S) score at Week 6. Scores range from 1 to 7. Lower scores indicate less severe illness.
Sheehan Disability Scale (SDS)	Day 1 and Week 6	Change from Baseline (Visit 2) in the Sheehan Disability Scale (SDS) total score at Week 6. Scores range from 0 to 30. Lower scores indicate less impairment to activities.

Trial Locations

Locations (27)

Cenexel Research - Decatur; 🇺🇸 Decatur, Georgia, United States

Preferred Research Partners; 🇺🇸 Little Rock, Arkansas, United States

Cenexel CIT - Bellflower; 🇺🇸 Bellflower, California, United States

Behavioral Research Specialists; 🇺🇸 Glendale, California, United States

Synergy Research; 🇺🇸 Lemon Grove, California, United States

Excell Research; 🇺🇸 Oceanside, California, United States

NCR Research Institute; 🇺🇸 Orange, California, United States

Cenexel CIT - Riverside; 🇺🇸 Riverside, California, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Cenexel CNR - Sherman Oaks; 🇺🇸 Sherman Oaks, California, United States

Viking Clinical Research; 🇺🇸 Temecula, California, United States

Mountain View Clinical Research; 🇺🇸 Denver, Colorado, United States

CT Clinical Research Associates; 🇺🇸 Cromwell, Connecticut, United States

Gulfcoast Clinical Research Center; 🇺🇸 Fort Myers, Florida, United States

Clinical Neuroscience Solutions - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

West Broward Outpatient Clinic; 🇺🇸 Lauderhill, Florida, United States

Segal Trials - North Miami; 🇺🇸 Miami Lakes, Florida, United States

Clinical Neuroscience Solutions - Orlando; 🇺🇸 Orlando, Florida, United States

Cenexel ACMR - Atlanta; 🇺🇸 Atlanta, Georgia, United States

Northwest Clinical Trials; 🇺🇸 Boise, Idaho, United States

Chicago Research Center; 🇺🇸 Chicago, Illinois, United States

Cenexel HRI - Berlin; 🇺🇸 Berlin, New Jersey, United States

Summit Research Network; 🇺🇸 Portland, Oregon, United States

Clinical Neuroscience Solutions - Memphis; 🇺🇸 Memphis, Tennessee, United States

Donald J. Garcia, Jr.; 🇺🇸 Austin, Texas, United States

Futuresearch Trials of Dallas; 🇺🇸 Dallas, Texas, United States

Core Clinical Research; 🇺🇸 Everett, Washington, United States