A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)

ClinicalTrials.gov ID: NCT07621237

Public ClinicalTrials.gov record NCT07621237. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Oct 17, 2026, 8:00 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this clinical trial is to learn if a drug called TNX-102 SL works to treat moderate to severe major depressive disorder in adults. It will also learn about the safety of TNX-102 SL. The main questions it aims to answer are: Does TNX-102 SL improve depression symptoms according to a depression symptom rating scale? What medical problems do participants have when taking TNX-102 SL? Researchers will compare TNX-102 SL to a placebo (a look-alike substance that contains no drug) to see if TNX-102 SL works to treat major depressive disorder. Participants will: Take TNX-102 SL or a placebo every night at bedtime for 6 weeks Visit the clinic once every 2 weeks for checkups and tests

Study identification

NCT ID: NCT07621237
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Tonix Pharmaceuticals, Inc.; Industry
Enrollment: 360 participants

Conditions and interventions

Conditions

Interventions

TNX-102 SL Drug
Placebo sublingual tablet Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 25, 2026 (Actual)
Primary completion: Feb 2028 (Estimated)
Completion: Feb 2028 (Estimated)
Last update posted: Sep 25, 2026

2026 – 2028

United States locations

U.S. sites: 27
U.S. states: 14
U.S. cities: 27

Facility	City	State	ZIP	Site status
IMA Clinical Research- Phoenix	Phoenix	Arizona	85012	Recruiting
Buena Park Research Center	Buena Park	California	90620	Recruiting
Inland Psychiatric Medical Group, Inc. - Chino	Chino	California	91710	Recruiting
Synergy Research - San Diego	Lemon Grove	California	91945	Recruiting
Nrc Research Institute	Orange	California	92868	Recruiting
Artemis Institute For Clinical Research - San Diego	San Diego	California	92123	Recruiting
Sunwise Clinical Research, Llc	Walnut Creek	California	94596	Recruiting
Clinical Neuroscience Solutions Inc. - Jacksonville	Jacksonville	Florida	32256	Recruiting
K2 Medical Research - Maitland	Maitland	Florida	32751	Recruiting
Central Miami Medical Institute Llc.	Miami	Florida	33125	Recruiting
Medical Research Group of Central Florida	Orange City	Florida	32763	Recruiting
Clinical Neuroscience Solutions Inc. - Orlando	Orlando	Florida	32801	Recruiting
K2 Medical Research - Tampa	Tampa	Florida	33634	Recruiting
Evergreen Clinical Trials	Norcross	Georgia	30092	Recruiting
Chicago Research Center	Chicago	Illinois	60634	Recruiting
Delricht Research - New Orleans	New Orleans	Louisiana	70115	Withdrawn
Delricht Research - Rockville	Rockville	Maryland	20852	Recruiting
Activmed Practices & Research, Llc - Methuen	Methuen	Massachusetts	01844	Recruiting
Redbird Research	Las Vegas	Nevada	89119	Recruiting
Ima Clinical Research - Nyc Midtown	New York	New York	10036	Recruiting
Coastal Carolina Research Center	North Charleston	South Carolina	29405	Recruiting
Clinical Neuroscience Solutions Inc. - Memphis	Mephis	Tennessee	38119	Recruiting
Austin Clinical Trial Partners	Austin	Texas	78737	Recruiting
FutureSearch Trials of Dallas	Dallas	Texas	75251	Recruiting
Revival Research Institute, Llc - McKinney, Tx	McKinney	Texas	75071	Recruiting
Delricht Research - Plano	Plano	Texas	75024	Recruiting
Boeson Research Pvu	Provo	Utah	84604	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07621237, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 25, 2026 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07621237 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →