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Recruiting NCT07621237

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

Phase II Interventional Major Depressive Episode (MDE) Major Depressive Disorder (MDD) Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TNX-102 SL, Placebo sublingual tablet.
Who it may be relevant to
Registry conditions: Major Depressive Episode (MDE), Major Depressive Disorder (MDD), Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

Interventions

  • Drug TNX-102 SL
    Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.
  • Drug Placebo sublingual tablet
    Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.

Primary outcome measures

  • Change from Baseline (Visit 2) in the MADRS total score at Week 6. [Time frame: From Day 1 to Week 6]
Secondary outcome measures (4)
  • Change from Baseline (Visit 2) in the Clinician Global Impression - Severity (CGI-S) score at Week 6 [Time frame: From Day 1 to Week 6]
  • Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6 [Time frame: From Day 1 to Week 6]
  • Change from Baseline (Visit 2) in the MADRS total score at Week 4. [Time frame: From Day 1 to Week 4]
  • Change from Baseline (Visit 2) in the MADRS total score at Week 2. [Time frame: From Day 1 to Week 2]

Eligibility criteria

Inclusion criteria

  • Primary DSM-5 diagnosis of current MDD.
  • The duration of the current MDE must be between 6 weeks and 18 months.
  • Without psychotic or catatonic features.
  • Capable of reading and understanding English and able to provide written informed consent to participate.

Exclusion criteria

  • Diagnosis of DSM-5-defined lifetime bipolar disorder (I, II, or unspecified), schizophrenia, schizoaffective disorder, MDD with psychotic features, other psychotic disorder, or antisocial personality disorder; current (past month) obsessive-compulsive disorder; current (past month) posttraumatic stress disorder; current (past 3 months) anorexia nervosa,
  • Diagnosis of borderline personality disorder that is known, suspected
  • Participants with comorbid generalized anxiety disorder (GAD), social anxiety disorder (SAD), or panic disorder are excluded only if the GAD, SAD, or panic disorder is considered the primary psychiatric diagnosis, rather than MDD.
  • Participants with treatment refractory MDD, ie, previously having failed in their lifetime ≥2 treatments (due to inadequate efficacy) with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence.
  • History of substance use disorder and/or alcohol use disorder during the preceding 12 months
  • Use of antidepressants (including ketamine/esketamine, St. John's Wort, S-adenosyl methionine, and/or trazodone used as an antidepressant) within 4 weeks of Baseline (Visit 2), except for fluoxetine, which must not be within 6 weeks of Baseline (Visit 2)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 25 centers
  • IMA Clinical Research- Phoenix — Phoenix
  • Inland Psychiatric Medical Group, Inc. - Chino — Chino
  • Synergy Research - San Diego — Lemon Grove
  • Nrc Research Institute — Orange
  • Artemis Institute For Clinical Research - San Diego — San Diego
  • Sunwise Clinical Research, Llc — Walnut Creek
  • Clinical Neuroscience Solutions Inc. - Jacksonville — Jacksonville
  • K2 Medical Research - Maitland — Maitland
  • … and 17 more centers

Identifiers

NCT: NCT07621237 · TNX-CY-MD201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗