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Randomized, double-blind study of the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder.
Am J Geriatr Psychiatry. 2013 Aug; 21(8):769-84.AJ

Abstract

OBJECTIVES

This study assessed the efficacy and tolerability of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder (MDD).

DESIGN

An 11-week (9-week randomized; 2-week posttreatment phase), double-blind, placebo-controlled, Phase III study (D1448C00014).

SETTING

A total of 53 centers in Argentina, Estonia, Finland, Russia, Ukraine, and the United States.

PARTICIPANTS

A total of 338 patients (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of MDD, age ≥66 years, Hamilton Rating Scale for Depression [HAM-D] total score ≥22, HAM-D Item 1 [depressed mood] score ≥2) were randomized (mean age: 71.3 years).

INTERVENTION

Patients were randomized to quetiapine XR (n = 166; flexible-dosing 50-300 mg/day) or placebo (n = 172).

MEASUREMENTS

Primary outcome was Montgomery Åsberg Depression Rating Scale (MADRS) total score change from randomization at Week 9.

RESULTS

At Week 9, quetiapine XR (least squares [LS] means: -16.33, standard error [SE]: 0.95; mean change: -16.0, standard deviation [SD]: 9.3) significantly reduced MADRS total score from randomization versus placebo (LS means [SE]: -8.79 [0.94]; mean [SD]: -9.0 [9.9]); significant improvements were also seen at Week 1 (LS means [SE]: -4.65 [0.53] versus -2.56 [0.53], respectively; mean [SD]: -4.3 [5.1] versus -2.4 [3.7], respectively). At Week 9, secondary outcome variables significantly improved with quetiapine XR versus placebo, including MADRS response (≥50% reduction in total score); MADRS remission (total score ≤8); HAM-D total, HAM-A total, HAM-A psychic and somatic cluster, and Clinical Global Impressions-Severity of Illness (CGI-S) total scores; proportion of patients with CGI-Improvement score of 2 or less; Q-LES-Q-SF% maximum total, Pittsburgh Sleep Quality Index global, and pain Visual Analog Scale scores. Common adverse events (>10% patients with quetiapine XR) were somnolence, headache, dry mouth, and dizziness.

CONCLUSION

In elderly patients with MDD, quetiapine XR monotherapy (50-300 mg/day, flexibly dosed) is effective at improving depressive symptoms, with symptom improvement observed as early as Week 1. Overall tolerability and safety were consistent with the known profile of quetiapine.

Authors+Show Affiliations

Department of Psychiatry, Helsinki University Central Hospital, Helsinki, Finland. Electronic address: heikki.katila@hus.fi.No 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

23567397

Citation

Katila, Heikki, et al. "Randomized, Double-blind Study of the Efficacy and Tolerability of Extended Release Quetiapine Fumarate (quetiapine XR) Monotherapy in Elderly Patients With Major Depressive Disorder." The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry, vol. 21, no. 8, 2013, pp. 769-84.
Katila H, Mezhebovsky I, Mulroy A, et al. Randomized, double-blind study of the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder. Am J Geriatr Psychiatry. 2013;21(8):769-84.
Katila, H., Mezhebovsky, I., Mulroy, A., Berggren, L., Eriksson, H., Earley, W., & Datto, C. (2013). Randomized, double-blind study of the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder. The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry, 21(8), 769-84. https://doi.org/10.1016/j.jagp.2013.01.010
Katila H, et al. Randomized, Double-blind Study of the Efficacy and Tolerability of Extended Release Quetiapine Fumarate (quetiapine XR) Monotherapy in Elderly Patients With Major Depressive Disorder. Am J Geriatr Psychiatry. 2013;21(8):769-84. PubMed PMID: 23567397.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blind study of the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder. AU - Katila,Heikki, AU - Mezhebovsky,Irina, AU - Mulroy,Amy, AU - Berggren,Lovisa, AU - Eriksson,Hans, AU - Earley,Willie, AU - Datto,Catherine, Y1 - 2013/02/06/ PY - 2011/02/01/received PY - 2011/12/06/revised PY - 2012/01/10/accepted PY - 2013/4/10/entrez PY - 2013/4/10/pubmed PY - 2014/11/5/medline KW - Atypical antipsychotic KW - elderly KW - extended release KW - major depressive disorder KW - quetiapine XR SP - 769 EP - 84 JF - The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry JO - Am J Geriatr Psychiatry VL - 21 IS - 8 N2 - OBJECTIVES: This study assessed the efficacy and tolerability of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder (MDD). DESIGN: An 11-week (9-week randomized; 2-week posttreatment phase), double-blind, placebo-controlled, Phase III study (D1448C00014). SETTING: A total of 53 centers in Argentina, Estonia, Finland, Russia, Ukraine, and the United States. PARTICIPANTS: A total of 338 patients (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of MDD, age ≥66 years, Hamilton Rating Scale for Depression [HAM-D] total score ≥22, HAM-D Item 1 [depressed mood] score ≥2) were randomized (mean age: 71.3 years). INTERVENTION: Patients were randomized to quetiapine XR (n = 166; flexible-dosing 50-300 mg/day) or placebo (n = 172). MEASUREMENTS: Primary outcome was Montgomery Åsberg Depression Rating Scale (MADRS) total score change from randomization at Week 9. RESULTS: At Week 9, quetiapine XR (least squares [LS] means: -16.33, standard error [SE]: 0.95; mean change: -16.0, standard deviation [SD]: 9.3) significantly reduced MADRS total score from randomization versus placebo (LS means [SE]: -8.79 [0.94]; mean [SD]: -9.0 [9.9]); significant improvements were also seen at Week 1 (LS means [SE]: -4.65 [0.53] versus -2.56 [0.53], respectively; mean [SD]: -4.3 [5.1] versus -2.4 [3.7], respectively). At Week 9, secondary outcome variables significantly improved with quetiapine XR versus placebo, including MADRS response (≥50% reduction in total score); MADRS remission (total score ≤8); HAM-D total, HAM-A total, HAM-A psychic and somatic cluster, and Clinical Global Impressions-Severity of Illness (CGI-S) total scores; proportion of patients with CGI-Improvement score of 2 or less; Q-LES-Q-SF% maximum total, Pittsburgh Sleep Quality Index global, and pain Visual Analog Scale scores. Common adverse events (>10% patients with quetiapine XR) were somnolence, headache, dry mouth, and dizziness. CONCLUSION: In elderly patients with MDD, quetiapine XR monotherapy (50-300 mg/day, flexibly dosed) is effective at improving depressive symptoms, with symptom improvement observed as early as Week 1. Overall tolerability and safety were consistent with the known profile of quetiapine. SN - 1545-7214 UR - https://www.unboundmedicine.com/medline/citation/23567397/Randomized_double_blind_study_of_the_efficacy_and_tolerability_of_extended_release_quetiapine_fumarate__quetiapine_XR__monotherapy_in_elderly_patients_with_major_depressive_disorder_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1064-7481(13)00015-8 DB - PRIME DP - Unbound Medicine ER -