Clinical trial NCT05686408: Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Depressive Disorder
Depressive Symptoms
Depressive Disorder, Major
Depressive Episode
Depression Severe
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rho, Inc.
First posted: 2023-01-17
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Day 1 and Week 6
Secondary outcomes:
measure: Clinical Global Impression of Severity (CGI-S)
timeFrame: Day 1 and Week 6
measure: Sheehan Disability Scale (SDS)
timeFrame: Day 1 and Week 6
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Bellflower
country: United States
facility: Cenexel CIT - Bellflower
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists
state: California
city: Lemon Grove
country: United States
facility: Synergy Research
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Orange
country: United States
facility: NCR Research Institute
state: California
city: Riverside
country: United States
facility: Cenexel CIT - Riverside
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Cenexel CNR - Sherman Oaks
state: California
city: Temecula
country: United States
facility: Viking Clinical Research
state: California
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Cromwell
country: United States
facility: CT Clinical Research Associates
state: Connecticut
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions - Jacksonville
state: Florida
city: Lauderhill
country: United States
facility: West Broward Outpatient Clinic
state: Florida
city: Miami Lakes
country: United States
facility: Segal Trials - North Miami
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions - Orlando
state: Florida
city: Atlanta
country: United States
facility: Cenexel ACMR - Atlanta
state: Georgia
city: Decatur
country: United States
facility: Cenexel Research - Decatur
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Berlin
country: United States
facility: Cenexel HRI - Berlin
state: New Jersey
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions - Memphis
state: Tennessee
city: Austin
country: United States
facility: Donald J. Garcia, Jr.
state: Texas
city: Dallas
country: United States
facility: Futuresearch Trials of Dallas
state: Texas
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
Study officials:
affiliation: Tonix Pharmaceuticals
name: Gregory Sullivan, MD
role: STUDY_DIRECTOR
References: