TNX-102 SL for Major Depressive Disorder
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Recruiting
Phase 2
Interventional Study
Major Depressive Episode (MDE)
Major Depressive Disorder (MDD)
Depression
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 360 (estimated)
- Sponsor
- Tonix Pharmaceuticals, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with major depressive disorder to see if a new treatment called TNX-102 SL helps improve their symptoms. Participants will take the treatment or a placebo for 6 weeks and visit the clinic every two weeks for checkups.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with major depressive disorder.
- My current depressive episode has lasted between 6 weeks and 18 months.
- I do not have psychotic or catatonic features.
- I can read and understand English.
- I can provide written consent to participate.
You may not be able to join if
- I have been diagnosed with bipolar disorder or schizophrenia.
- I have had obsessive-compulsive disorder or posttraumatic stress disorder in the past month.
- I have had anorexia nervosa in the past three months.
- I have borderline personality disorder.
- I have treatment-resistant major depressive disorder.
- I have a history of substance use or alcohol use disorder in the past year.
- I have used antidepressants in the past four weeks, except for fluoxetine which I have not used in the past six weeks.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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About This Trial
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?
Res…
Trial Locations
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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 Cr…
Contacts