Clinical trialNCT05686408CompletedPhase 2Interventional

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

SponsorTonix Pharmaceuticals, Inc.Enrollment132DepressionDepression SevereDepressive DisorderDepressive Disorder, MajorDepressive EpisodeDepressive Symptoms

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Gregory Sullivan, MD
Tonix Pharmaceuticals
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

27 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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
Futuresearch Trials of Dallas
Dallas, Texas, United States
Core Clinical Research
Everett, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboTNX-601 ER

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 Mar 2023
Primary completion: 29 Sept 2023
Completion: 29 Sept 2023
Last update posted: 17 Feb 2025
Registered enrollment: 132
Registry id: NCT05686408

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.