Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05686408 | Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) | PHASE2 | COMPLETED | 132 | — | — | Mar 2, 2023 | Sep 29, 2023 | Feb 17, 2025 | 27 | United States |
Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
| Arm | Type | Description |
|---|---|---|
| TNX-601 ER, 39.4 mg | EXPERIMENTAL | 1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo tablet taken orally once daily for 6 weeks. |
| Name | Type | Description |
|---|---|---|
| TNX-601 ER | DRUG | Patients will take 1 tablet orally once daily for 6 weeks. |
| Placebo | DRUG | Patients will take 1 tablet orally once daily for 6 weeks. |
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...