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

Completed · Phase 2 · Has a placebo group

Conditions studied: Depression, Depressive Disorder, Depressive Symptoms, Depressive Disorder, Major, Depressive Episode, Depression Severe

In brief

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).

Key facts

Study ID

NCT05686408

Run by

Tonix Pharmaceuticals, Inc.

People needed

132

Starts

2023-03-02

Expected to finish

2023-09-29

Last updated by the study team

2025-02-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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