Major Depressive Episode study: TNX-102 SL
Official title A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
ClinicalTrials.gov ID: NCT07621237
What this study is testing
What is TNX-102 SL?
An investigational oral medication being studied for the treatment of major depressive episodes.
Also referred to as cyclobenzaprine, cyclobenzaprine HCl.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether TNX-102 SL improves depression symptoms compared to a pretend treatment. It also looks at how safe the drug is.
- Who it's for
- You may be able to join if you are an adult with moderate to severe depression and can take a nightly pill.
- What's involved
- You will take either TNX-102 SL or a placebo every night at bedtime. You will visit the clinic every two weeks for check‑ups and tests.
- Time commitment
- The study lasts six weeks, with clinic visits every two weeks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Diagnosis of DSM-5-defined lifetime bipolar disorder (I, II, or unspecified), schizophrenia, schizoaffective disorder, MDD with psychotic features...
- 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...
- Participants with treatment refractory MDD, ie, previously having failed in their lifetime ≥2 treatments (due to inadequate how well it works) with...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Buena Park, California, United States
- Chino, California, United States
- Lemon Grove, California, United States
- Orange, California, United States
- San Diego, California, United States
- Walnut Creek, California, United States
- Jacksonville, Florida, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Norcross, Georgia, United States
- Chicago, Illinois, United States
- Rockville, Maryland, United States
- Methuen, Massachusetts, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- North Charleston, South Carolina, United States
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Buena Park, California, United States; Chino, California, United States; Lemon Grove, California, United States; Orange, California, United States; San Diego, California, United States and 20 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.