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Recruiting Phase 2 Interventional

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.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 3:18 PM 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

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
May 31, 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028
Last update posted
Jun 1, 2026

2026 – 2028

United States locations

U.S. sites
25
U.S. states
14
U.S. cities
25
Facility City State ZIP Site status
IMA Clinical Research- Phoenix Phoenix Arizona 85012 Not yet recruiting
Inland Psychiatric Medical Group, Inc. - Chino Chino California 91710 Not yet recruiting
Synergy Research - San Diego Lemon Grove California 91945 Not yet recruiting
Nrc Research Institute Orange California 92868 Not yet recruiting
Artemis Institute For Clinical Research - San Diego San Diego California 92123 Not yet recruiting
Sunwise Clinical Research, Llc Walnut Creek California 94596 Not yet recruiting
Clinical Neuroscience Solutions Inc. - Jacksonville Jacksonville Florida 32256 Not yet recruiting
K2 Medical Research - Maitland Maitland Florida 32751 Not yet recruiting
Central Miami Medical Institute Llc. Miami Florida 33125 Not yet recruiting
Medical Research Group of Central Florida Orange City Florida 32763 Not yet recruiting
Clinical Neuroscience Solutions Inc. - Orlando Orlando Florida 32801 Recruiting
K2 Medical Research - Tampa Tampa Florida 33634 Not yet recruiting
Evergreen Clinical Trials Norcross Georgia 30092 Not yet recruiting
Chicago Research Center Chicago Illinois 60634 Not yet recruiting
Delricht Research - New Orleans New Orleans Louisiana 70115 Recruiting
Delricht Research - Rockville Rockville Maryland 20852 Not yet recruiting
Activmed Practices & Research, Llc - Methuen Methuen Massachusetts 01844 Not yet recruiting
Redbird Research Las Vegas Nevada 89119 Not yet recruiting
Ima Clinical Research - Nyc Midtown New York New York 10036 Not yet recruiting
Coastal Carolina Research Center North Charleston South Carolina 29405 Not yet recruiting
Clinical Neuroscience Solutions Inc. - Memphis Mephis Tennessee 38119 Not yet recruiting
Austin Clinical Trial Partners Austin Texas 78737 Not yet recruiting
Revival Research Institute, Llc - McKinney, Tx McKinney Texas 75071 Not yet recruiting
Delricht Research - Plano Plano Texas 75024 Not yet recruiting
Boeson Research Pvu Provo Utah 84604 Not yet 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 Jun 1, 2026 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07621237 live on ClinicalTrials.gov.

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