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Major Depressive Episode (MDE)Mental healthDrugPhase 2

What this study is

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

What's being tested

  • TNX-102 SL

    Intervention · DRUG

    Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.

  • Placebo sublingual tablet

    Intervention · DRUG

    Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.

Study details

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)
Sponsor
Tonix Pharmaceuticals, Inc.
Conditions
Major Depressive Episode (MDE) · Major Depressive Disorder (MDD) · Depression
Enrolling
360 people
Starts
2026-06-25
Est. completion
2028-02
Design
Quadruple-blind, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗