BACKGROUND: Patients with treatment-resistant major depressive disorder (MDD) remain a common clinical challenge. METHODS: This 6-week, randomised, open-label, rater-blinded trial evaluated once-daily extended-release quetiapine fumarate (quetiapine XR; 300mg/day) as add-on to ongoing antidepressant and quetiapine XR monotherapy (300mg/day) compared with add-on lithium (0.6-1.2mmol/L) in patients with treatment-resistant MDD. Primary efficacy measure: change in Montgomery Åsberg Depression Rating Scale (MADRS) total score from randomisation to week 6 with a pre-specified non-inferiority limit of 3 points on the MADRS. RESULTS: At week 6, both add-on quetiapine XR (n=231) and quetiapine XR monotherapy (n=228) were non-inferior to add-on lithium (n=229); least squares means (LSM) differences (97.5% CI) in MADRS total score changes were -2.32 (-4.6, -0.05) and -0.97 (-3.24, 1.31), respectively. LSM MADRS total score change was numerically greater at day 4 for both quetiapine XR groups (add-on and monotherapy; p<0.01) compared with add-on lithium. At week 6, the differences between groups for the secondary endpoints of MADRS response (≥50% reduction in total score), MADRS remission (total score ≤10, add-on quetiapine XR only) and Clinical Global Impressions ('much'/'very much' improved) were numerically similar. Overall tolerability was consistent with the known profiles of both treatments. LIMITATIONS: Limitations included the open-label study design (although MADRS and laboratory measurements were performed by treatment-blinded raters) and relatively short study duration with no assessments in the continuation phase. CONCLUSIONS: Add-on quetiapine XR (300mg/day) and quetiapine XR monotherapy (300mg/day) are non-inferior to add-on lithium in the management of patients with treatment-resistant MDD.

Extended-release quetiapine fumarate (quetiapine XR) monotherapy and quetiapine XR or lithium as add-on to antidepressants in patients with treatment-resistant major depressive disorder

DELL'OSSO, LILIANA;
2013

Abstract

BACKGROUND: Patients with treatment-resistant major depressive disorder (MDD) remain a common clinical challenge. METHODS: This 6-week, randomised, open-label, rater-blinded trial evaluated once-daily extended-release quetiapine fumarate (quetiapine XR; 300mg/day) as add-on to ongoing antidepressant and quetiapine XR monotherapy (300mg/day) compared with add-on lithium (0.6-1.2mmol/L) in patients with treatment-resistant MDD. Primary efficacy measure: change in Montgomery Åsberg Depression Rating Scale (MADRS) total score from randomisation to week 6 with a pre-specified non-inferiority limit of 3 points on the MADRS. RESULTS: At week 6, both add-on quetiapine XR (n=231) and quetiapine XR monotherapy (n=228) were non-inferior to add-on lithium (n=229); least squares means (LSM) differences (97.5% CI) in MADRS total score changes were -2.32 (-4.6, -0.05) and -0.97 (-3.24, 1.31), respectively. LSM MADRS total score change was numerically greater at day 4 for both quetiapine XR groups (add-on and monotherapy; p<0.01) compared with add-on lithium. At week 6, the differences between groups for the secondary endpoints of MADRS response (≥50% reduction in total score), MADRS remission (total score ≤10, add-on quetiapine XR only) and Clinical Global Impressions ('much'/'very much' improved) were numerically similar. Overall tolerability was consistent with the known profiles of both treatments. LIMITATIONS: Limitations included the open-label study design (although MADRS and laboratory measurements were performed by treatment-blinded raters) and relatively short study duration with no assessments in the continuation phase. CONCLUSIONS: Add-on quetiapine XR (300mg/day) and quetiapine XR monotherapy (300mg/day) are non-inferior to add-on lithium in the management of patients with treatment-resistant MDD.
Michael, Bauer; Dell'Osso, Liliana; Siegfried, Kasper; William, Pitchot; Eva Dencker, Vansvik; Jürgen, Köhler; Leif, Jørgensen; Stuart A., Montgomery
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11568/256742
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