Table 2.
Key Study End Pointsa
| Outcome Measure | n | mITT-LOCF | n | Observed Cases |
| MADRS total score, mean (SD) | ||||
| Wk 12 change | 23 | −13.1 (7.1)* | 14 | −14.6 (5.6)* |
| Wk 24 change | 23 | −15.3 (8.1)* | 13 | −19.1 (5.5)* |
| Weight change, mean (SD), % | ||||
| Wk 12 change | 23 | −4.0 (4.6)* | 14 | −6.1 (4.7)* |
| Wk 24 change | 23 | −5.3 (6.5)* | 13 | −9.2 (6.2)* |
| CGI-I responders, n (% [95% CI])b | ||||
| Wk 12 score | 20 | 18 (90.0 [76.9–100]) | 14 | 12 (85.7 [67.4–100]) |
| Wk 24 score | 20 | 19 (95.0 [85.4–100]) | 12 | 12 (100 [100–100]) |
| IDS-SR total score, mean (SD) | ||||
| Wk 12 change | 22 | … | 14 | −20.1 (12.5)* |
| Wk 24 change | 22 | −22.2 (14.0)* | 13 | −26.9 (13.7)* |
| BES total score, mean (SD) | … | |||
| Wk 12 change | 21 | −14.7 (10.0)* | … | … |
| Wk 24 change | 21 | −16.1 (9.6)* | ||
| Serum leptin levels, mean (SD), ng/mLc | … | |||
| Wk 12 change | 7 | −30.1 (24.8)** | … | … |
| Wk 24 change | 9 | −19.8 (19.1)** | ||
| Serum ghrelin levels, mean (SD), pg/mLd | … | |||
| Wk 12 change | 9 | 73.1 (165.0) | … | … |
| Wk 24 change | 10 | 162.3 (150.2)** | ||
| Salivary cortisol levels, mean (SD), nmol/Le | … | |||
| Wk 12 change | 17 | −0.4 (16.0) | … | … |
| Wk 24 change | 17 | −4.4 (15.8) |
a
P values are based on a test that assesses if mean change from baseline is significantly different from zero.
b
CGI-I responders: CGI-I score ≤ 2 (much/very much improved).
c
Mean (SD) baseline leptin levels: 64.6 (21.1) ng/mL.
d
Mean (SD) baseline ghrelin levels: 1073.2 (459.9) pg/mL.
e
Mean (SD) salivary baseline cortisol levels: 17.3 (14.6) nmol/L.
*
P < .001.
**
P < .05.
Abbreviations: BES = Binge Eating Scale, CGI-S = Clinical Global Impressions–Improvement, IDS-SR = Inventory of Depressive Symptomatology—Self-Report, MADRS = Montgomery-Asberg Depression Rating Scale, mITT-LOCF = modified intent-to-treat–last observation carried forward.
Symbol: … = data not collected.