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

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)

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).

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Depression; Depressive Symptoms; Depressive Disorder, Major; Depressive Episode; Depression Severe
• Intervention / Treatment: Drug: TNX-601 ER; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Project Manager; Phone Number: 619-991-0553; Email: ashild.peters@tonixpharma.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners
  • California
    • Bellflower, California, United States, 90706
      • Cenexel CIT - Bellflower
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists
    • Lemon Grove, California, United States, 91945
      • Synergy Research
    • Oceanside, California, United States, 92056
      • Excell Research
    • Orange, California, United States, 92868
      • NCR Research Institute
    • Riverside, California, United States, 92506
      • Cenexel CIT - Riverside
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • Sherman Oaks, California, United States, 91403
      • Cenexel CNR - Sherman Oaks
    • Temecula, California, United States, 92951
      • Viking Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • CT Clinical Research Associates
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Gulfcoast Clinical Research Center
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions - Jacksonville
    • Lauderhill, Florida, United States, 33319
      • West Broward Outpatient Clinic
    • Miami Lakes, Florida, United States, 33016
      • Segal Trials - North Miami
    • Orlando, Florida, United States, 32801
      • Clinical Neuroscience Solutions - Orlando
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Cenexel ACMR - Atlanta
    • Decatur, Georgia, United States, 30030
      • Cenexel IResearch - Decatur
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
  • Illinois
    • Chicago, Illinois, United States, 60634
      • Chicago Research Center
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Cenexel HRI - Berlin
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions - Memphis
  • Texas
    • Austin, Texas, United States, 78737
      • Donald J. Garcia, Jr.
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas
  • Washington
    • Everett, Washington, United States, 98201
      • Core Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TNX-601 ER, 39.4 mg; 1x TNX-601 ER, 39.4 mg, pill taken orally once daily for 6 weeks.	Drug: TNX-601 ER; Patients will take 1 pill orally once daily for 6 weeks.; Other Names: Tianeptine
Placebo Comparator: Placebo; Placebo pill taken orally once daily for 6 weeks.	Drug: Placebo; Patients will take 1 pill orally once daily for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression of Severity (CGI-S)	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.	Day 1 and Week 6
Sheehan Disability Scale (SDS)	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.	Day 1 and Week 6

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.
• Collaborators: Rho, Inc.
• Investigators: Study Director: Gregory Sullivan, MD, Tonix Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Tricyclic; Tianeptine
• Other Study ID Numbers: TNX-TI-M201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No