Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies

2011 ◽  
Vol 26 (8) ◽  
pp. 614-628 ◽  
Author(s):  
Dan J. Stein ◽  
Borwin Bandelow ◽  
Charles Merideth ◽  
Bengt Olausson ◽  
Johan Szamosi ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Extended Release ◽  
Generalised Anxiety Disorder ◽  
Quetiapine Fumarate ◽  
Pooled Data ◽  
Quetiapine Xr

Analysis of Pooled Data: Once-daily Extended Release Quetiapine Fumarate (Quetiapine XR) Monotherapy in Patients with Major Depressive Disorder (MDD)

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
S. Montgomery ◽  
R. Weisler ◽  
W. Earley ◽  
M. Åstrom ◽  
A. Lazarus
Keyword(s):  
Extended Release ◽  
Primary Outcome ◽  
Individual Item ◽  
Major Depressive ◽  
Double Blind ◽  
Once Daily ◽  
Quetiapine Fumarate ◽  
Pooled Data ◽  
Quetiapine Xr ◽  
Item Scores

Aim:To evaluate efficacy and tolerability of quetiapine XR monotherapy in patients with MDD.Methods:Data were analysed from two 6-week, multicentre, double-blind, placebo-controlled studies (D1448C00001, D1448C00002), prospectively designed to be pooled. Outpatients received quetiapine XR 150mg/day (n=315), 300mg/day (n=323), placebo (n=330). Primary outcome: change at Week 6 in MADRS total scores. Other assessments: MADRS individual item scores, HAM-A total scores, MADRS response and remission; AE reporting.Results:Quetiapine XR 150mg/day and 300mg/day reduced MADRS total scores at Week 6 (-14.7 and -14.7; p< 0.001) versus placebo (-11.1); significant reductions were also seen at Week 1 (p< 0.001).Subgroup analyses showed the therapeutic effect of quetiapine XR was neither limited to nor driven by factors such as gender, age or depression severity.Quetiapine XR demonstrated consistent improvements in MADRS items: both doses significantly improved 8/10 items at Week 6 versus placebo. At Week 6, MADRS response (≥50% decrease in total score) was 52.7% (p< 0.001), 49.5% (p< 0.001) versus 33.0%; MADRS remission (total score ≤10) was 33.7% (p< 0.01), 34.7% (p< 0.01) versus 24.2% for quetiapine XR 150mg/day and 300mg/day and placebo, respectively. Quetiapine XR 150mg/day and 300mg/day improved HAM-A total scores versus placebo at Week 1 (-4.6 [p< 0.01], -4.7 [p< 0.01], -3.6) and Week 6 (-8.1 [p< 0.001], -7.9 [p< 0.001], -6.2). Common AEs (≥10%) were dry mouth, sedation, somnolence, dizziness, headache and nausea with quetiapine XR.Conclusion:In patients with MDD, quetiapine XR monotherapy improved a broad range of depressive symptoms, with improvements seen from Week 1. Quetiapine XR was generally well tolerated.

scholarly journals Evaluation of adjunct extended-release quetiapine fumarate on sleep disturbance and quality in patients with major depressive disorder and an inadequate response to on-going antidepressant therapy

2013 ◽  
Vol 16 (8) ◽  
pp. 1755-1765 ◽  
Author(s):  
Michael Bauer ◽  
Roger S. McIntyre ◽  
Johan Szamosi ◽  
Hans Eriksson
Keyword(s):  
Sleep Disturbance ◽  
Extended Release ◽  
Rating Scale ◽  
Antidepressant Therapy ◽  
Inadequate Response ◽  
Madrs Total Score ◽  
Major Depressive ◽  
Quetiapine Fumarate ◽  
Quetiapine Xr ◽  
Disturbance Factor

Abstract Sleep disturbance is common in depression and is a risk factor for recurrence and suicide. This analysis evaluated the effects of adjunct extended-release quetiapine fumarate (quetiapine XR) on sleep disturbance and quality in patients with major depressive disorder (MDD) and an inadequate response to on-going antidepressant therapy. Pooled data from two 6-wk, randomized, double-blind, placebo-controlled trials were analysed post hoc. Patients received once-daily quetiapine XR [(150 mg/d), n = 309; (300 mg/d), n = 307] or placebo (n = 303) adjunct to on-going antidepressant therapy. Analyses included: change from randomization in Montgomery-Åsberg Depression Rating Scale (MADRS) Item 4 (reduced sleep) score; Hamilton Rating Scale for Depression (HAMD) Items 4 (insomnia-early), 5 (insomnia-middle) and 6 (insomnia-late) scores; HAMD sleep disturbance factor (Items 4+5+6); Pittsburgh Sleep Quality Index (PSQI) global score. Change in MADRS total score was also evaluated in patients stratified by HAMD sleep disturbance factor score (high ⩾4 and low < 4) at randomization. At week 6, adjunct quetiapine XR (150 and 300 mg/d) reduced MADRS Item 4, HAMD Items 4, 5 and 6, HAMD sleep disturbance factor and PSQI global scores from randomization vs. placebo (all p < 0.001). In patients with high sleep disturbance, quetiapine XR (both doses) improved depressive symptoms (MADRS total score) vs. placebo from week 1 onwards (p < 0.01). Adjunct quetiapine XR improved sleep disturbance and quality vs. placebo in patients with MDD and an inadequate response to on-going antidepressant treatment, and was effective against depressive symptoms in patients experiencing high sleep disturbance.

Efficacy and tolerability of quetiapine XR 400/600/800mg/day in acute schizophrenia: a post-hoc analysis of data from two pooled randomised studies

2011 ◽  
Vol 26 (S2) ◽  
pp. 1411-1411
Author(s):  
R. Kahn ◽  
A. Kalali ◽  
U. Gustafsson ◽  
S. Nyberg
Keyword(s):  
Dose Response ◽  
Extended Release ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Once Daily ◽  
Quetiapine Fumarate ◽  
Post Hoc Analysis ◽  
Response Efficacy ◽  
Quetiapine Xr ◽  
Post Hoc

IntroductionData from two, identically designed, placebo-controlled, randomised, double-blind clinical trials (D1444C00132+D1444C00133) for once-daily extended-release quetiapine fumarate (QTP-XR) were pooled and analysed.ObjectiveEvaluate dose response, efficacy and safety for QTP-XR in schizophrenia.MethodsPost-hoc analysis of data from patients receiving QTP-XR 400, 600, 800 mg/day or placebo. Endpoints: least squares means (LSM) change from baseline to Day 42 in PANSS total and positive and negative subscale scores. No corrections for multiplicity were performed. Adverse events (AEs) were recorded.Results914 patients were included; PANSS scores were assessed in the MITT population (n = 889). LSM change from baseline in PANSS total score diverged significantly from placebo at: Day 14 for QTP-XR 800 mg/day (-15.3 vs -12.1 for placebo; p = 0.018); Day 21 for 600 mg/day (-17.3 vs -14.2; p = 0.039); Day 42 for 400 mg/day (-19.2 vs -15.4; p = 0.033).Jonckheere-Terpstra analysis of change in PANSS total score at Day 42 showed a significant QTP-XR dose response (p = 0.0196; p < 0.001 with placebo). PANSS positive scores diverged by Day 21 for both QTP-XR 800 (-5.7 vs -4.8; p = 0.049) and 600 mg/day (-5.8 vs -4.8; p = 0.046). PANSS negative scores diverged by Day 21 (-4.0 vs -3.2; p = 0.040) and 42 (-4.8 vs -3.6; p = 0.009) for QTP-XR 800 and 600 mg/day, respectively. AEs occurred in 59.4%, 66.5%, 62.1% and 56.2% of patients in the QTP-XR 800, 600, 400 mg/day and placebo groups, respectively. Most common AEs were somnolence, dry mouth, sedation, insomnia, dizziness, headache, constipation and nausea.ConclusionsQTP-XR was generally well tolerated and demonstrated efficacy that increased with dose in schizophrenia.Financial support: AstraZeneca.

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