Table 1.
Summary of RCTs of agomelatine for the treatment of generalized anxiety disorder
| Study | Drugs (mg/d) | Patient (n) | Mean age (yr) | Duration (wk) | Baseline MADRS | Hamilton Anxiety Rating Scale | Study location | |||
|---|---|---|---|---|---|---|---|---|---|---|
|
| ||||||||||
| Baseline | Mean changea | Responseb | Remissionc | |||||||
| Stein et al. 2008 [17] | PBO | 58 | 41.7 | 12 | 11.7 ± 2.1 | 28.6 ± 3.8 | −13.2 ± 9.5 | 27 (46.6) | 13 (22.4) | S. Africa, FN |
| AGO (25−50) | 63 | 41.7 | 11.6 ± 2.9 | 29.0 ± 4.4 | −16.6 ± 8.9 | 42 (66.7) | 26 (41.3) | |||
| Stein et al. 2012 [18] | PBO | 113 | 47.0 | 26 | NA | 6.0 ± 2.6 | 3.6 ± 8.4 | NA | NA | CN, DN, ET, FN, HG, and SW |
| AGO (25−50) | 112 | 45.9 | NA | 5.9 ± 2.7 | −1.6 ± 7.7 | NA | NA | |||
| Stein et al. 2014 [28] | PBO | 131 | 43.0 | 12 | 12.3 ± 2.4 | 28.2 ± 3.4 | −10.6 ± 9.5 | 48 (36.6) | 26 (19.9) | FN, RU, PL, CZ, SL, AG, S. Korea |
| AGO (25−50) | 139 | 43.6 | 12.0 ± 2.4 | 28.6 ± 4.0 | −15.6 ± 9.4 | 89 (64.0) | 51 (36.7) | |||
| Stein et al. 2017 [29] | PBO | 140 | 44.1 | 12 | 11.5 ± 2.6 | 28.8 ± 3.6 | −6.9 ± 9.2 | 32 (22.9) | 18 (12.9) | FN, RU, PL, SL, Ukraine |
| AGO total | 268 | 43.9 | 11.6 ± 2.4 | 28.8 ± 3.7 | −15.91 ± 8.19 | 164 (61.2) | 88 (32.9) | |||
| AGO (10) | 130 | 43.6 | 11.8 ± 2.4 | 28.6 ± 3.5 | −13.87 ± 8.7 | 67 (51.5) | 33 (25.4) | |||
| AGO (25) | 138 | 44.1 | 11.4 ± 2.4 | 29.0 ± 3.7 | −18.7 ± 7.7 | 97 (70.3) | 55 (39.9) | |||
Values are presented as number (%) or mean ± standard deviation.
RCT, randomized, double-blind, placebo-controlled trials; MADRS, Montgomery and Åsberg Depression Rating Scale; SD, standard deviation; PBO, Placebo; AGO, Agomelatine; NA, not applicable; S. Africa, South Africa; FN, Finland; CN, Canada; DN, Denmark; ET, Estonia, HG, Hungary; SW, Sweden; RU, Russia; PL, Poland; CZ, Czech Republic; SL, Slovakia; AG, Argentina; S. Korea, South Korea; HAM-A, Hamilton Anxiety Rating Scale.
a
Primary efficacy measure; bResponse: 50% or more decrement of HAM-A from baseline to endpoint; c Remission: 7 or less in total HAM-A score at endpoint