Mean (±SE) Montgomery–Åsberg Depression Rating Scale Total Score (Observed Cases).
depressive symptoms
REMISSION
IND Induction, OP/MA optimization/Maintenance. Note: Responders from the induction phase of the SUSTAIN-3 study and responders from parent studies were to enter the optimization/maintenance phase. The greater variability of the mean MADRS total score at later time points likely reflects the smaller number of participants at these timepoints, as reflected in the corresponding sample sizes.The proportion of responders (defined as ≥50% reduction in MADRS total score; observed cases) increased over time during the induction phase, from 15.0% (66/439) on day 8 to 50.6% (224/443) on day 28 and to 49.2% (224/455) at endpoint of the induction phase. A total of 35.6% (162/455) of participants were in remission (MADRS total score ≤12; observed cases) at the induction endpoint, and 50.9% (464/911) and 46.1% (511/1108) at year 1 and endpoint of the optimization/maintenance phase, respectively.Improvement in depressive symptoms was also noted based on decrease in PHQ-9 total score over the course of the induction phase (mean [SD] change from baseline to phase endpoint: −5.8 [5.84]; 95% CI: −6.32 to −5.24), with improvement maintained during the optimization/maintenance phase (change from phase baseline to endpoint: +0.9 [6.04]; 95% CI: 0.50 to 1.21) (Fig. Illness severity, as assessed by the CGI-S, improved from baseline (median of 5) to the endpoint of the induction phase (median [range] change from baseline, −1.0 [−5; 1]) and remained stable over the optimization/maintenance phase (median [range] change: 0.0 [−5; 4]), suggesting maintenance of the antidepressant effect. More than half of participants had CGI-S scores indicating normal/borderline/mild illness (scores of 1, 2, or 3) at endpoint of the induction phase (55.9%) and at endpoint of the optimization/maintenance phase (57.3%) (Fig. 