Symptoms of depression and anxiety
The changes in severity of depressive and anxiety symptoms as measured by HAM-D24, HAM-A, and CGI-S during the double-blind phase and the open-label extension phase are summarized in Table 5 and Figs 3–5. These results indicate that the improvements achieved during the double-blind phase were maintained when study participants were continued on or switched to vortioxetine, with scores decreasing further from the open-label baseline values irrespective of the original double-blind assigned treatment. For example, the mean (±SD) HAM-D24 scores decreased from 31.2 (±5.5) at the double-blind lead-in baseline to 17.6 (±9.4) at the open-label baseline, with a further improvement to 9.7 (±8.2) at the final visit (OC analysis). These results reflect a total mean change from double-blind baseline to the end point of the open-label study of –21.5 (±9.4) (Fig. 3). Response (defined as a ≥50% decrease in the HAM-D24 score from the open-label baseline to the final visit) was achieved in 423/829 (51.0%) study participants (OC analysis). Improvements in HAM-D24 scores were evident irrespective of the dosage assignment in the lead-in trial (i.e. there was no difference in response rates on the basis of treatment in the lead-in study). Decreases in HAM-D24 scores ranged from 16.2 to 25.0 across all vortioxetine dose groups relative to the double-blind baseline, with a further improvement of 4.0–10.2 points at the final visit relative to the open-label baseline. Remission, defined as a HAM-D17 total score of up to 7, was achieved in 461/829 (55.6%) study participants at the final visit. These overall improvements in HAM-D24 scores were similar to those observed in the subgroup of study participants who received duloxetine during the double-blind trial (US study). Here, that subgroup showed a decrease of 18.2 points at the final visit relative to the double-blind baseline and a decrease of 3.4 points relative to the open-label baseline.
Table 5  Efficacy measures
Fig. 3  Mean HAM-D24 total scores by study visit. BL, baseline; HAM-D24, 24-item Hamilton Depression Scale.
Fig. 4  Mean HAM-A total scores by study visit. BL, baseline; HAM-A, Hamilton Anxiety Scale.
Fig. 5  Mean CGI-S total scores by study visit. BL, baseline; CGI-S, Clinical Global Impressions Scale – Severity of Illness Scale.   Similar changes in symptom severity were noted for the MADRS total score, MADRS response (defined as a ≥50% decrease in the total score from baseline), and MADRS remission (defined as a total score≤10). Mean changes in HAM-A and CGI-S scores from double-blind baseline to the final visit were –12.4 (±7.4) and –2.5 (±1.3) points, respectively, among those treated with vortioxetine, with decreases continuing after the initiation of the open-label phase (Table 5 and Figs 4 and 5). For the double-blind duloxetine group, the improvement in HAM-A and CGI-S scores was –9.5 (±6.88) and –2.18 (±1.255) points, respectively. For patient-reported outcomes, study participants receiving vortioxetine experienced improvements in all SF-36 subscale scores from open-label baseline for all previous treatment groups. Similarly, study participants experienced improvements from double-blind baseline and open-label baseline in the mean SDS scores and in individual items, indicating continued improvement.