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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02741791 | A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder | PHASE3 | COMPLETED | 312 | — | — | Mar 1, 2016 | Mar 20, 2020 | Mar 24, 2021 | 74 | United States |
The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
| Arm | Type | Description |
|---|---|---|
| AXS-05 | EXPERIMENTAL | - |
| Bupropion | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AXS-05 | DRUG | AXS-05 taken daily for 6 weeks. |
| Bupropion | DRUG | Buproprion taken daily for 6 weeks. |
Key Inclusion Criteria: * Currently meets DSM-V criteria for MDD * History of inadequate response to 1 or 2 adequate antidepressant treatments * Body mass index (BMI) between 18 and 40 kg/m2, inclusive * Agree to use adequate method of contraception for the duration of the study * Additional criter...