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RecruitingPhase 2

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 6 visits
  • Time periods mentioned: 6 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether TNX-102 SL helps adults with moderate to severe major depression and checks its safety. Participants take the drug or a placebo (a look-alike with no drug) at bedtime for 6 weeks and visit the clinic every 2 weeks.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have major depression as your main current mental health diagnosis.
  • Your current period of depression has lasted 6 weeks to 18 months.
  • Have no psychotic symptoms (loss of touch with reality) or catatonic symptoms (major problems with movement or responding).
  • Can read and understand English and give written consent to join.

Who can't join

  • Have ever had bipolar disorder, schizophrenia, schizoaffective disorder, depression with psychotic symptoms, another disorder involving loss of touch with reality, or antisocial personality disorder.
  • Have had obsessive-compulsive disorder (unwanted thoughts and repeated actions) or posttraumatic stress disorder (symptoms after trauma) in the past month, or anorexia nervosa (an eating disorder) in the past 3 months.
  • Have known or suspected borderline personality disorder.
  • Have generalized anxiety, social anxiety, or panic disorder as your main mental health diagnosis rather than depression.
  • Have tried at least 2 antidepressant treatments from at least 2 different drug groups without enough improvement, despite taking them as directed at a suitable dose for enough time.
  • Have had a drug or alcohol use disorder in the past 12 months.
  • Have used antidepressants within 4 weeks before the baseline visit (Visit 2), or fluoxetine within 6 weeks. This includes ketamine, esketamine, St. John's Wort, S-adenosyl methionine, and trazodone used for depression.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (27)

AZ

CA

FL

GA

IL

LA

MA

MD

NV

NY

SC

TN

TX

UT