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Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant treatment: a multicentre, randomized, double-blind, placebo-controlled study.
Int J Neuropsychopharmacol. 2010 Aug; 13(7):917-32.IJ

Abstract

This study evaluated once-daily extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with major depressive disorder (MDD) with inadequate response to ongoing antidepressant treatment. In this 8-wk (6-wk active treatment/2-wk post-treatment drug-discontinuation/follow-up), multicentre, double-blind, placebo-controlled, Phase III study, 446 patients were randomized to quetiapine XR 150 mg/d, 300 mg/d, or placebo adjunct to ongoing antidepressant treatment. The primary endpoint was the change from randomization to week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. At week 6, MADRS total scores significantly improved with quetiapine XR 300 mg/d vs. placebo (-14.7 vs. -11.7, p<0.01). Quetiapine XR 300 mg/d showed significant improvements vs. placebo for: MADRS total score from week 1 onwards; MADRS response [(> or = 50% total score reduction) 58.9% vs. 46.2%, p<0.05] and remission [(total score < or = 8) 42.5% vs. 24.5%, p<0.01] rates; Hamilton Depression Rating Scale (HAMD) (-13.53 vs. -10.80, p<0.01) and Clinical Global Impression-Severity of illness (CGI-S) change (-1.52 vs. -1.23, p<0.05) at week 6. For quetiapine XR 150 mg/d, improvements were not significantly different vs. placebo, except for MADRS (weeks 1 and 2) and HAMD (week 6) total scores. Withdrawal rates due to adverse events (AEs) were: quetiapine XR 150 mg/d 11.5%, 300 mg/d 19.5%, and placebo 0.7%. The most common AEs (>10%) with quetiapine XR were dry mouth, somnolence, sedation, dizziness, constipation, nausea, insomnia, headache, and fatigue. In this study, quetiapine XR 300 mg/d as adjunctive therapy in patients with MDD with an inadequate response to ongoing antidepressant treatment was effective at week 6. However, the difference from placebo for quetiapine XR 150 mg/d at week 6 was not statistically significant. Both doses studied (150 and 300 mg/d) were effective at week 1 and generally well tolerated.

Authors+Show Affiliations

Alpine Clinic, Lafayette, IN 47905, USA. elkhalilmd@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20175941

Citation

El-Khalili, Nizar, et al. "Extended-release Quetiapine Fumarate (quetiapine XR) as Adjunctive Therapy in Major Depressive Disorder (MDD) in Patients With an Inadequate Response to Ongoing Antidepressant Treatment: a Multicentre, Randomized, Double-blind, Placebo-controlled Study." The International Journal of Neuropsychopharmacology, vol. 13, no. 7, 2010, pp. 917-32.
El-Khalili N, Joyce M, Atkinson S, et al. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant treatment: a multicentre, randomized, double-blind, placebo-controlled study. Int J Neuropsychopharmacol. 2010;13(7):917-32.
El-Khalili, N., Joyce, M., Atkinson, S., Buynak, R. J., Datto, C., Lindgren, P., & Eriksson, H. (2010). Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant treatment: a multicentre, randomized, double-blind, placebo-controlled study. The International Journal of Neuropsychopharmacology, 13(7), 917-32. https://doi.org/10.1017/S1461145710000015
El-Khalili N, et al. Extended-release Quetiapine Fumarate (quetiapine XR) as Adjunctive Therapy in Major Depressive Disorder (MDD) in Patients With an Inadequate Response to Ongoing Antidepressant Treatment: a Multicentre, Randomized, Double-blind, Placebo-controlled Study. Int J Neuropsychopharmacol. 2010;13(7):917-32. PubMed PMID: 20175941.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant treatment: a multicentre, randomized, double-blind, placebo-controlled study. AU - El-Khalili,Nizar, AU - Joyce,Mark, AU - Atkinson,Sarah, AU - Buynak,Robert J, AU - Datto,Catherine, AU - Lindgren,Petter, AU - Eriksson,Hans, Y1 - 2010/02/23/ PY - 2010/2/24/entrez PY - 2010/2/24/pubmed PY - 2011/1/11/medline SP - 917 EP - 32 JF - The international journal of neuropsychopharmacology JO - Int. J. Neuropsychopharmacol. VL - 13 IS - 7 N2 - This study evaluated once-daily extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with major depressive disorder (MDD) with inadequate response to ongoing antidepressant treatment. In this 8-wk (6-wk active treatment/2-wk post-treatment drug-discontinuation/follow-up), multicentre, double-blind, placebo-controlled, Phase III study, 446 patients were randomized to quetiapine XR 150 mg/d, 300 mg/d, or placebo adjunct to ongoing antidepressant treatment. The primary endpoint was the change from randomization to week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. At week 6, MADRS total scores significantly improved with quetiapine XR 300 mg/d vs. placebo (-14.7 vs. -11.7, p<0.01). Quetiapine XR 300 mg/d showed significant improvements vs. placebo for: MADRS total score from week 1 onwards; MADRS response [(> or = 50% total score reduction) 58.9% vs. 46.2%, p<0.05] and remission [(total score < or = 8) 42.5% vs. 24.5%, p<0.01] rates; Hamilton Depression Rating Scale (HAMD) (-13.53 vs. -10.80, p<0.01) and Clinical Global Impression-Severity of illness (CGI-S) change (-1.52 vs. -1.23, p<0.05) at week 6. For quetiapine XR 150 mg/d, improvements were not significantly different vs. placebo, except for MADRS (weeks 1 and 2) and HAMD (week 6) total scores. Withdrawal rates due to adverse events (AEs) were: quetiapine XR 150 mg/d 11.5%, 300 mg/d 19.5%, and placebo 0.7%. The most common AEs (>10%) with quetiapine XR were dry mouth, somnolence, sedation, dizziness, constipation, nausea, insomnia, headache, and fatigue. In this study, quetiapine XR 300 mg/d as adjunctive therapy in patients with MDD with an inadequate response to ongoing antidepressant treatment was effective at week 6. However, the difference from placebo for quetiapine XR 150 mg/d at week 6 was not statistically significant. Both doses studied (150 and 300 mg/d) were effective at week 1 and generally well tolerated. SN - 1469-5111 UR - https://www.unboundmedicine.com/medline/citation/20175941/Extended_release_quetiapine_fumarate__quetiapine_XR__as_adjunctive_therapy_in_major_depressive_disorder__MDD__in_patients_with_an_inadequate_response_to_ongoing_antidepressant_treatment:_a_multicentre_randomized_double_blind_placebo_controlled_study_ L2 - https://academic.oup.com/ijnp/article-lookup/doi/10.1017/S1461145710000015 DB - PRIME DP - Unbound Medicine ER -