A Phase 2 interventional study of TNX-601 ER and Placebo in Depression, Depressive Disorder and Depressive Symptoms, sponsored by Tonix Pharmaceuticals, Inc.. Completed at 27 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Tonix Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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).
8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 132 is above the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →Tonix Pharmaceuticals, Inc. is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Have a primary DSM-5 diagnosis of current MDD.
Exclusion Criteria:
Psychiatric History:
1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.
Drug: TNX-601 ER
Placebo tablet taken orally once daily for 6 weeks.
Drug: Placebo
Patients will take 1 tablet orally once daily for 6 weeks.
Also known as: Tianeptine
Patients will take 1 tablet orally once daily for 6 weeks.
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
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
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
| Milestone | Placebo | TNX-601 ER, 39.4 mg |
|---|---|---|
| Started | 68 | 64 |
| Completed | 58 | 53 |
| Not completed | 10 | 11 |
Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
| units on a scale | Placebo | TNX-601 ER, 39.4 mg |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) | -12.8 ± 1.32 | -12.7 ± 1.30 |
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.
| units on a scale | Placebo | TNX-601 ER, 39.4 mg |
|---|---|---|
| Clinical Global Impression of Severity (CGI-S) | -1.2 ± 0.16 | -1.0 ± 0.15 |
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.
| units on a scale | Placebo | TNX-601 ER, 39.4 mg |
|---|---|---|
| Sheehan Disability Scale (SDS) | -7.3 ± 0.97 | -5.8 ± 0.95 |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/68 (0%) | 1/68 (1.5%) | 3/68 (4.4%) |
| TNX-601 ER, 39.4 mg | 0/64 (0%) | 2/64 (3.1%) | 7/64 (10.9%) |
| Event | Placebo | TNX-601 ER, 39.4 mg |
|---|---|---|
| SeizureNervous system disorders | 0/68 | 1/64 |
| Generalized tonic-clonic seizureNervous system disorders | 0/68 | 1/64 |
| SyncopeNervous system disorders | 0/68 | 1/64 |
| DermatomyositisSkin and subcutaneous tissue disorders | 1/68 | 0/64 |
| Event | Placebo | TNX-601 ER, 39.4 mg |
|---|---|---|
| NauseaGastrointestinal disorders | 3/68 | 7/64 |
| Age, Continuous(years) | Placebo | TNX-601 ER, 39.4 mg | Total |
|---|---|---|---|
| Mean | 41.8 ± 13.87 | 40.2 ± 11.92 | 41.0 ± 12.94 |
| Sex: Female, Male(Participants) | Placebo | TNX-601 ER, 39.4 mg | Total |
|---|---|---|---|
| Female | 39 | 38 | 77 |
| Male | 29 | 26 | 55 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | TNX-601 ER, 39.4 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 12 | 16 | 28 |
| Not Hispanic or Latino | 56 | 48 | 104 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | TNX-601 ER, 39.4 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 3 | 4 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 19 | 14 | 33 |
| White | 44 | 45 | 89 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Region of Enrollment(participants) | Placebo | TNX-601 ER, 39.4 mg | Total |
|---|---|---|---|
| United States | 68 | 64 | 132 |
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Tonix Pharmaceuticals, Inc.