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
Open Access
- 23 February 2010
- journal article
- research article
- Published by Oxford University Press (OUP) in International Journal of Neuropsychopharmacology
- Vol. 13 (07), 917-932
- https://doi.org/10.1017/s1461145710000015
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–Åsberg 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, pvs. placebo for: MADRS total score from week 1 onwards; MADRS response [(⩾50% total score reduction) 58.9% vs. 46.2%, pvs. 24.5%, pvs. −10.80, pvs. −1.23, p10%) 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.Keywords
This publication has 34 references indexed in Scilit:
- Extended Release Quetiapine Fumarate Monotherapy for Major Depressive Disorder: Results of a Double-Blind, Randomized, Placebo-Controlled StudyCNS Spectrums, 2009
- Extended-Release Quetiapine as Adjunct to an Antidepressant in Patients With Major Depressive DisorderBritish Journal of Psychology, 2009
- Clinical Factors Associated With Treatment Resistance in Major Depressive DisorderBritish Journal of Psychology, 2007
- The Efficacy and Safety of Aripiprazole as Adjunctive Therapy in Major Depressive DisorderBritish Journal of Psychology, 2007
- World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Unipolar Depressive Disorders in Primary CareThe World Journal of Biological Psychiatry, 2007
- Efficacy of Quetiapine Monotherapy in Bipolar I and II DepressionJournal of Clinical Psychopharmacology, 2006
- A Randomized, Double-Blind, Placebo-Controlled Trial of Quetiapine in the Treatment of Bipolar I or II DepressionAmerican Journal of Psychiatry, 2005
- A prospective randomized single-blind, multicenter trial comparing the efficacy and safety of paroxetine with and without quetiapine therapy in depression associated with anxietyInternational Journal of Psychiatry in Clinical Practice, 2004
- Efficacy of quetiapine for the treatment of schizophrenia: a combined analysis of three placebo-controlled trialsCurrent Medical Research and Opinion, 2004
- A RATING SCALE FOR EXTRAPYRAMIDAL SIDE EFFECTSActa Psychiatrica Scandinavica, 1970