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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05686408
Other study ID # TNX-TI-M201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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