Table 2.
Depression scores at baseline and before and after the maintenance phase
| Baseline | T2 | T5 | |||||||
| N | Mean, SD | 95% CI | N | Mean, SD | 95% CI | N | Mean, SD | 95% CI | |
| All patients | |||||||||
| HAM-D-17 (ITT) | 25 | 22.2, 4.9 | 20.2–24.2 | 25 | 15.0, 8.7 | 11.4–18.6 | 25 | 16.6, 10.5 | 12.2–20.9 |
| HAM-D-17 (OC) | 21 | 14.5, 8.6 | 10.6–18.4 | 18 | 13.6, 9.2 | 9.0–18.2 | |||
| MADRS (ITT) | 25 | 34.0, 5.8 | 31.6–36.5 | 25 | 22.9, 12.7 | 17.7–28.1 | 25 | 24.3, 15.1 | 18.1–30.5 |
| MADRS (OC) | 21 | 21.8, 12.9 | 15.9–27.6 | 18 | 19.8, 14.4 | 12.7–27.0 | |||
| IDS-SR (ITT) | 25 | 49.4, 9.8 | 45.3–53.4 | 25 | 38.8, 18.4 | 31.2–46.5* | 25 | 35.0, 21.4 | 26.1–43.8* |
| IDS-SR (OC) | 21 | 38.0, 19.0 | 29.3–46.6 | 18 | 29.9, 20.3 | 19.8–40.0 | |||
| Responders† | |||||||||
| HAM-D-17 | 10 | 21.5, 6.1 | 17.1–25.9 | 10 | 8.0, 4.7 | 4.7–11.3 | 8 | 5.5, 5.0 | 1.3–9.8 |
| MADRS | 10 | 31.2, 6.5 | 26.6–35.9 | 10 | 11.8, 7.4 | 6.5–17.11 | 8 | 8.3, 8.5 | 1.2–15.3 |
| IDS-SR | 10 | 42.0, 9.4 | 35.3–48.7 | 10 | 23.2, 12.0 | 14.6–31.8 | 8 | 14.0, 9.7 | 5.9–22.1 |
| Non-responders† | |||||||||
| HAM-D-17 (ITT) | 15 | 22.6, 4.0 | 20.4–24.8 | 15 | 19.7, 7.6 | 15.5–23.9 | 17 | 21.8, 7.9 | 17.7–25.8 |
| HAM-D-17 (OC) | 11 | 20.5, 6.8 | 15.9–25.0 | 10 | 20.1, 6.0 | 15.8–24.4 | |||
| MADRS (ITT) | 15 | 35.9, 4.7 | 33.4–38.5 | 15 | 31.3, 9.1 | 26.0–36.5 | 17 | 31.8, 10.9 | 26.2–37.4 |
| MADRS (OC) | 11 | 30.8, 9.6 | 24.4–37.3 | 10 | 29.1, 11.1 | 21.2–37.1 | |||
| IDS-SR (ITT) | 15 | 54.2, 6.7 | 50.6–58.0 | 15 | 49.3, 14.1 | 41.5–57.1 | 17 | 44.8, 18.0 | 35.6–54.1 |
| IDS-SR (OC) | 11 | 51.4, 13.4 | 42.4–60.4 | 10 | 42.6, 17.5 | 30.1–55.1 | |||
*Difference from T2 to T5: p=0.008
†Response status based on HAM-D-17 score at T2 (baseline and T2) or T5 (T5), NB: OC and ITT values for responders are similar.
HAM-D-17, 17-item Hamilton Depression Rating Scale; IDS-SR, self-reported Inventory of Depressive Symptomatology;ITT, intention-to-treat; MADRS, Montgomery-Asberg Depression Rating Scale; OC, observed-case; T2, start of the maintenance phase; T5, end of the maintenance phase.