Depression, Major Depressive Disorder (MDD), Major Depressive Episode (MDE)
Conditions
Keywords
Depression, TNX-102 SL, Cyclobenzaprine
Brief summary
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
DRUGTNX-102 SL
Participants will take 5.6 mg of TNX-102 SL ( 2 x 2.8 mg TNX-102 SL tablets) daily at bedtime.
Participants will take placebo ( 2 x placebo sublingual tablets) daily at bedtime.
Sponsors
Tonix Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline (Visit 2) in the MADRS total score at Week 6. | From Day 1 to Week 6 | Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline (Visit 2) in the Clinician Global Impression - Severity (CGI-S) score at Week 6 | From Day 1 to Week 6 | Change from Baseline (Visit 2) in the Clinical Global Impression of Severity Scale (CGI-S) score at Week 6. Scores range from 1 to 5. Lower scores indicate less severe illness. |
| Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6 | From Day 1 to Week 6 | Change from Baseline (Visit 2) in the PROMIS Sleep Disturbance T-score at Week 6. The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance). |
| Change from Baseline (Visit 2) in the MADRS total score at Week 4. | From Day 1 to Week 4 | Change from Baseline (Visit 2) in the MADRS total score at Week 4. Scores range from 0 to 60. Lower scores indicate less depression. |
| Change from Baseline (Visit 2) in the MADRS total score at Week 2. | From Day 1 to Week 2 | Change from Baseline (Visit 2) in the MADRS total score at Week 2. Scores range from 0 to 60. Lower scores indicate less depression. |
Countries
United States
Contacts
CONTACTTimothy Roush
Outcome results
None listed