3.1 Effectiveness
A significant improvement in depression severity assessed by the HAMD-17 scale was observed after initiation of agomelatine treatment. The mean total HAMD-17 score decreased compared with baseline by 2.6 ± 3.3 (P<0.0001) at week 2, and by 6.7 ± 5.3 and 10.9 ± 4.9 at the week 4 and 8 visits (P<0.0001 for both), respectively (Figure 1). Agomelatine was also associated with a significant improvement in symptoms of anxiety. Item 10 (anxiety psychic) of the HAMD-17 score was reduced from 1.4±0.9 at baseline to 0.5±0.6 at week 8 (Figure 2); the mean change from baseline was 0.9 (95% CI -1.1 -0.7, P<0.0001). Item 11 (anxiety somatic) of the HAMD-17 score was reduced from 1.3±0.8 at baseline to 0.6±0.6, with a mean change of 0.7 (95% CI -0.8 -0.5; P<0.0001) at week 8 (Figure 3).
There was a significant improvement in depression severity at each study visit based on investigators’ clinical judgement. Mean CGI-I score decreased from 3.4±0.8 at week 2 to 2.3±1.0 at week 4 (mean change -1.0; P<0.0001) and to 1.3±0.6 at week 8 (mean change -2.0 vs week 2 visit; P<0.0001) (Figure 4). At the week 8 visit, 81.4% of patients responded to treatment with agomelatine having at least a 50% decrease from baseline in total HAMD-17 score. In addition, 71.6% of patients had a remission of depression (total HAMD-17 score ≤7).
There was a significant improvement in patients’ QoL reflected by an increase in the mean scores of both the SF-36 physical (Figure 5) and mental components (Figure 6). The physical component increased from 39.70±8.41 at baseline to 45.80±7.69 at week 4 (mean change -6.20±8.64 vs baseline, P<0.0001), and to 50.50±5.70 at week 8 (mean change -11.10±7.30 vs baseline, P<0.0001). The SF-36 mental component score increased from 37.30±8.67 at baseline to 39.80±8.28 (week 2), 47.60±8.55 (week 4), and 58.70±6.91 (week 8) resulting in mean changes of 2.70±4.84, 10.50±6.89, and 21.40±8.92 at the week 2, 4 and 8 visits, respectively (P<0.0001 for all timepoints vs baseline).