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

Depression Clinical Trial

— UPLIFT  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05686408
• Other study ID #: TNX-TI-M201
• Status: Completed
• Phase: Phase 2
• Start date: March 2, 2023
• Est. completion date: September 29, 2023

Study information

• Verified date: March 2024
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• TNX-601 ER
Patients will take 1 pill orally once daily for 6 weeks.
• Placebo
Patients will take 1 pill orally once daily for 6 weeks.

Locations

Country	Name	City	State
United States	Cenexel ACMR - Atlanta	Atlanta	Georgia
United States	Donald J. Garcia, Jr.	Austin	Texas
United States	Cenexel CIT - Bellflower	Bellflower	California
United States	Cenexel HRI - Berlin	Berlin	New Jersey
United States	Northwest Clinical Trials	Boise	Idaho
United States	Chicago Research Center	Chicago	Illinois
United States	CT Clinical Research Associates	Cromwell	Connecticut
United States	Futuresearch Trials of Dallas	Dallas	Texas
United States	Cenexel IResearch - Decatur	Decatur	Georgia
United States	Mountain View Clinical Research	Denver	Colorado
United States	Core Clinical Research	Everett	Washington
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Behavioral Research Specialists	Glendale	California
United States	Clinical Neuroscience Solutions - Jacksonville	Jacksonville	Florida
United States	West Broward Outpatient Clinic	Lauderhill	Florida
United States	Synergy Research	Lemon Grove	California
United States	Preferred Research Partners	Little Rock	Arkansas
United States	Clinical Neuroscience Solutions - Memphis	Memphis	Tennessee
United States	Segal Trials - North Miami	Miami Lakes	Florida
United States	Excell Research	Oceanside	California
United States	NCR Research Institute	Orange	California
United States	Clinical Neuroscience Solutions - Orlando	Orlando	Florida
United States	Summit Research Network	Portland	Oregon
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

Sponsors (2)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.	Rho, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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