Depression, Depression Severe, Depressive Disorder, Depressive Disorder, Major, Depressive Episode, Depressive Symptoms
Conditions
Brief summary
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy versus placebo in patients with Major Depressive Disorder (MDD).
Interventions
DRUGTNX-601 ER
Patients will take 1 tablet orally once daily for 6 weeks.
DRUGPlacebo
Patients will take 1 tablet orally once daily for 6 weeks.
Sponsors
Rho, Inc.
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Female or male aged 18 to 65 years (inclusive). * Have a primary DSM-5 diagnosis of current MDD. 1. The duration of the current MDE must be at least 12 weeks. 2. Without psychotic or catatonic features.
Exclusion criteria
* Psychiatric History: 1. 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; lifetime opioid or lifetime sedative-hypnotic use disorders, as confirmed by the MINI 7.0.2. 2. Diagnosis of borderline personality disorder 3. Patients 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. (If MDD is the primary diagnosis, patients with comorbid GAD, SAD, and panic disorder are allowed for randomization). * Patients with treatment refractory MDD, ie, previously having in their lifetime failed ≥2 treatments with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) | Day 1 and 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 |
|---|---|---|
| Clinical Global Impression of Severity (CGI-S) | Day 1 and 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 7. Lower scores indicate less severe illness. |
| Sheehan Disability Scale (SDS) | Day 1 and Week 6 | Change from Baseline (Visit 2) in the Sheehan Disability Scale (SDS) total score at Week 6. Scores range from 0 to 30. Lower scores indicate less impairment to activities. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo tablet taken orally once daily for 6 weeks.
Placebo: Patients will take 1 tablet orally once daily for 6 weeks. | 68 |
| TNX-601 ER, 39.4 mg 1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.
TNX-601 ER: Patients will take 1 tablet orally once daily for 6 weeks. | 64 |
| Total | 132 |
Baseline characteristics
| Characteristic | Placebo | Total | TNX-601 ER, 39.4 mg |
|---|---|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 13.87 | 41.0 years STANDARD_DEVIATION 12.94 | 40.2 years STANDARD_DEVIATION 11.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 28 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 104 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 33 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 44 Participants | 89 Participants | 45 Participants |
| Region of Enrollment United States | 68 participants | 132 participants | 64 participants |
| Sex: Female, Male Female | 39 Participants | 77 Participants | 38 Participants |
| Sex: Female, Male Male | 29 Participants | 55 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 64 |
| other Total, other adverse events | 3 / 68 | 7 / 64 |
| serious Total, serious adverse events | 1 / 68 | 2 / 64 |
Outcome results
Primary
Montgomery Asberg Depression Rating Scale (MADRS)
Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
Time frame: Day 1 and Week 6
Population: Results reported for ITT population, which includes all randomized patients who received at least one dose of IP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Montgomery Asberg Depression Rating Scale (MADRS) | -12.8 units on a scale | Standard Error 1.32 |
| TNX-601 ER, 39.4 mg | Montgomery Asberg Depression Rating Scale (MADRS) | -12.7 units on a scale | Standard Error 1.3 |
Secondary
Clinical Global Impression of Severity (CGI-S)
Change from Baseline (Visit 2) in the Clinical Global Impression of Severity Scale (CGI-S) score at Week 6. Scores range from 1 to 7. Lower scores indicate less severe illness.
Time frame: Day 1 and Week 6
Population: Results reported for ITT population, which includes all randomized patients who received at least one dose of IP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Clinical Global Impression of Severity (CGI-S) | -1.2 units on a scale | Standard Error 0.16 |
| TNX-601 ER, 39.4 mg | Clinical Global Impression of Severity (CGI-S) | -1.0 units on a scale | Standard Error 0.15 |
Secondary
Sheehan Disability Scale (SDS)
Change from Baseline (Visit 2) in the Sheehan Disability Scale (SDS) total score at Week 6. Scores range from 0 to 30. Lower scores indicate less impairment to activities.
Time frame: Day 1 and Week 6
Population: Results reported for ITT population, which includes all randomized patients who received at least one dose of IP.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Sheehan Disability Scale (SDS) | -7.3 units on a scale | Standard Error 0.97 |
| TNX-601 ER, 39.4 mg | Sheehan Disability Scale (SDS) | -5.8 units on a scale | Standard Error 0.95 |