Phase 2 Study Comparing TNX-102 SL to Placebo for Treating Moderate to Severe Major Depressive Disorder in Adults

What this Trial Is About

Researchers are studying the effects of a drug called TNX-102 SL on adults with moderate to severe major depressive disorder MDD. This clinical trial aims to find out if TNX-102 SL improves depression symptoms compared to a placebo and to assess its safety. The study focuses on changes in depression symptoms measured by a rating scale over six weeks. Participants will take either 5.6 mg of TNX-102 SL two 2.8 mg tablets or placebo tablets every night at bedtime for six weeks. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the drug or placebo. Checkups and tests will take place at the clinic every two weeks during the treatment period. During the trial, participants will have depression symptom assessments and other evaluations to monitor safety and treatment effects. The main measurement is the change in depression rating scores from the start to week six. Participants will be closely followed throughout the six-week treatment, with regular visits every two weeks for monitoring and questionnaires.

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