Table 4.
IDS-SR assessed treatment-emergent depressive and anxiety symptomsa
| Symptomsb, n (%) | NB (n = 2482) | Placebo (n = 1430) |
|---|---|---|
| ≥1 postbaseline score of ≥2 | ||
| Item 5, sadness | 76 (3.5) | 45 (3.4) |
| Item 6, irritability | 93 (4.3) | 46 (3.4) |
| Item 7, anxiety/tension | 139 (6.4) | 64 (4.8) |
| Item 18, suicidality | 12 (0.6) | 5 (0.4) |
| ≥1 postbaseline score of ≥25 | 96 (4.4) | 55 (4.1) |
| ≥1 postbaseline score of ≥30 for subjects with baseline score ≥ 25 | 2 (0.1) | 2 (0.1) |
IDS-SR Inventory of Depressive Symptomatology, Subject-Rated, NB prolonged-release naltrexone 32 mg plus prolonged-release bupropion 360 mg (or 400 mg bupropion PR plus 32 mg naltrexone immediate release in study NB-201)
IDS-SR was not assessed in the phase 2 study (NB-201)
In the Phase 3 studies, subjects who reported treatment-emergent IDS-SR scores ≥ 2 on item 5 [sadness], item 6 [irritability], item 7 [anxiety/tension] or suicidality items, or a total score ≥ 25 (or ≥30 for subjects with a score ≥ 25 at screening) were further evaluated and, if indicated, referred to a psychologist or psychiatrist, as values that met these thresholds may have indicated the presence of a treatment emergent depressive or anxiety disorder