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

NCT05686408 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TNX-TI-M201
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 27

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Montgomery Asberg Depression Rating Scale (MADRS)

  Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.

  Day 1 and Week 6

Secondary Outcomes (2)

• Clinical Global Impression of Severity (CGI-S)

  Day 1 and Week 6

• Sheehan Disability Scale (SDS)

  Day 1 and Week 6

Study Arms (2)

TNX-601 ER, 39.4 mg

EXPERIMENTAL

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

Drug: TNX-601 ER

Placebo

PLACEBO COMPARATOR

Placebo tablet taken orally once daily for 6 weeks.

Drug: Placebo

Interventions

TNX-601 ER DRUG

Patients will take 1 tablet orally once daily for 6 weeks.

Also known as: Tianeptine

TNX-601 ER, 39.4 mg

Placebo DRUG

Patients will take 1 tablet orally once daily for 6 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead
• Rho, Inc.: collaborator

Study Sites (27)

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Cenexel CIT - Bellflower

Bellflower, California, 90706, United States

Location

Behavioral Research Specialists

Glendale, California, 91206, United States

Location

Synergy Research

Lemon Grove, California, 91945, United States

Location

Excell Research

Oceanside, California, 92056, United States

Location

NCR Research Institute

Orange, California, 92868, United States

Location

Cenexel CIT - Riverside

Riverside, California, 92506, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Cenexel CNR - Sherman Oaks

Sherman Oaks, California, 91403, United States

Location

Viking Clinical Research

Temecula, California, 92951, United States

Location

Mountain View Clinical Research

Denver, Colorado, 80209, United States

Location

CT Clinical Research Associates

Cromwell, Connecticut, 06416, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Clinical Neuroscience Solutions - Jacksonville

Jacksonville, Florida, 32256, United States

Location

West Broward Outpatient Clinic

Lauderhill, Florida, 33319, United States

Location

Segal Trials - North Miami

Miami Lakes, Florida, 33016, United States

Location

Clinical Neuroscience Solutions - Orlando

Orlando, Florida, 32801, United States

Location

Cenexel ACMR - Atlanta

Atlanta, Georgia, 30331, United States

Location

Cenexel Research - Decatur

Decatur, Georgia, 30030, United States

Location

Northwest Clinical Trials

Boise, Idaho, 83704, United States

Location

Chicago Research Center

Chicago, Illinois, 60634, United States

Location

Cenexel HRI - Berlin

Berlin, New Jersey, 08009, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Clinical Neuroscience Solutions - Memphis

Memphis, Tennessee, 38119, United States

Location

Donald J. Garcia, Jr.

Austin, Texas, 78737, United States

Location

Futuresearch Trials of Dallas

Dallas, Texas, 75231, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major

Interventions

tianeptine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Gregory Sullivan, MD
• Organization: Tonix Pharmaceuticals

greg.sullivan@tonixpharma.com

(862) 904-0355

Study Officials

• Gregory Sullivan, MD

  Tonix Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: March 2, 2023
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)