Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NRX-1074 · 3 trials · 2 indications
Change in Hamilton Depression Rating Scale HDRS-17
Observed side effects and changes in laboratory values
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| NRX-1074 1 mg | EXPERIMENTAL | NRX-1074 1 mg, intravenous |
| NRX-1074 5 mg | EXPERIMENTAL | NRX-1074 5 mg, intravenous |
| NRX-1074 10 mg | EXPERIMENTAL | NRX-1074 10 mg, intravenous |
| Drug: Placebo | PLACEBO_COMPARATOR | Single oral administration on Day 1 |
| Drug: NRX-1074 375 mg | EXPERIMENTAL | Single oral administration on Day 1 |
| Drug: NRX-1074 500 mg | EXPERIMENTAL | Single oral administration on Day 1 |
| Drug: NRX-1074 750 mg | EXPERIMENTAL | Single oral administration on Day 1 |
| NRX-1074, 1 mg | EXPERIMENTAL | 1 mg IV |
| NRX-1074, 5 mg | EXPERIMENTAL | 5 mg IV |
| NRX-1074, 10 mg IV | EXPERIMENTAL | 10 mg |
| NRX-1074, 50 mg IV | EXPERIMENTAL | 50 mg |
| NRX-1074, 25 mg PO | EXPERIMENTAL | 25 mg |
| NRX-1074, 125 mg PO | EXPERIMENTAL | 125 mg |
| Name | Type | Description |
|---|---|---|
| NRX-1074 1 mg | DRUG | Single intravenous administration of 1 mg into arm on Day 0 |
| Placebo | DRUG | Single intravenous injection into the arm on Day 0 |
| NRX-1074 5 mg | DRUG | Single intravenous injection of 5 mg into the arm on Day 0 |
| NRX-1074 10 mg | DRUG | Single intravenous injection of 10 mg into the arm on Day 0 |
| NRX-1074 375 mg | DRUG | Single oral administration of 375 mg consumption on Day 1 |
| NRX-1074 500 mg | DRUG | Single oral administration of 500 mg consumption on Day 1 |
| NRX-1074 750 mg | DRUG | Single oral administration of 750 mg consumption on Day 1 |
| NRX-1074 | DRUG | Single IV or PO administration |
Inclusion Criteria: * Male and female subjects * Aged 18 to 65 years * Meets Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD) * Current episode has lasted ≥ 8 weeks before Screening * HDRS-17 score ≥ 21 before beginning the wa...
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