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Double-blind, randomized study of extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder.
Int J Geriatr Psychiatry. 2013 Jun; 28(6):615-25.IJ

Abstract

OBJECTIVE

The objective of the study was to evaluate once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder (GAD).

METHODS

An 11-week (9-week treatment; 2-week posttreatment), randomized, double-blind, placebo-controlled study (D1448C00015) of flexibly-dosed quetiapine XR (50-300 mg/day) or placebo conducted at 47 sites (Estonia, Poland, Russia, Ukraine, and USA) between September 2006 and April 2008. Patients (≥66 years) with DSM-IV diagnosis of GAD, Hamilton Anxiety Rating Scale (HAM-A) total score of ≥20 with item 1 (anxious mood) and 2 (tension) scores of ≥2, Clinical Global Impressions-Severity of Illness (CGI-S) score of ≥4, and Montgomery Åsberg Depression Rating Scale (MADRS) total score of ≤16 were eligible for inclusion. Primary endpoint: week 9 change from randomization in HAM-A total score.

RESULTS

Patients were randomized to quetiapine XR (n = 223) or placebo (n = 227). At week 9, quetiapine XR significantly reduced HAM-A total score versus placebo (least squares mean -14.97 versus -7.21; p < 0.001); symptom improvement with quetiapine XR versus placebo was significant at week 1 (p < 0.001). At week 9, quetiapine XR demonstrated significant benefits over placebo for HAM-A response and remission rates, HAM-A psychic and somatic cluster, MADRS total, CGI-S, Pittsburgh Sleep Quality Index global, pain visual analog scale, and Quality of Life, Enjoyment and Satisfaction Questionnaire short form % maximum total scores and Clinical Global Impressions-Improvement (% patients with a score of 1/2) (all p < 0.001). Adverse events (>5% in either treatment group) included somnolence, dry mouth, dizziness, headache, and nausea.

CONCLUSIONS

Quetiapine XR (50-300 mg/day) monotherapy is effective in the short term in improving symptoms of anxiety in older patients with GAD, with symptom improvement seen as early as week 1. Tolerability findings were generally consistent with the known profile of quetiapine.

Authors+Show Affiliations

Boston Clinical Trials, Boston, MA, USA. irinamez@hotmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23070803

Citation

Mezhebovsky, Irina, et al. "Double-blind, Randomized Study of Extended Release Quetiapine Fumarate (quetiapine XR) Monotherapy in Older Patients With Generalized Anxiety Disorder." International Journal of Geriatric Psychiatry, vol. 28, no. 6, 2013, pp. 615-25.
Mezhebovsky I, Mägi K, She F, et al. Double-blind, randomized study of extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder. Int J Geriatr Psychiatry. 2013;28(6):615-25.
Mezhebovsky, I., Mägi, K., She, F., Datto, C., & Eriksson, H. (2013). Double-blind, randomized study of extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder. International Journal of Geriatric Psychiatry, 28(6), 615-25. https://doi.org/10.1002/gps.3867
Mezhebovsky I, et al. Double-blind, Randomized Study of Extended Release Quetiapine Fumarate (quetiapine XR) Monotherapy in Older Patients With Generalized Anxiety Disorder. Int J Geriatr Psychiatry. 2013;28(6):615-25. PubMed PMID: 23070803.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Double-blind, randomized study of extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder. AU - Mezhebovsky,Irina, AU - Mägi,Kairi, AU - She,Fahua, AU - Datto,Catherine, AU - Eriksson,Hans, Y1 - 2012/10/16/ PY - 2012/02/15/received PY - 2012/07/12/accepted PY - 2012/10/17/entrez PY - 2012/10/17/pubmed PY - 2014/1/1/medline SP - 615 EP - 25 JF - International journal of geriatric psychiatry JO - Int J Geriatr Psychiatry VL - 28 IS - 6 N2 - OBJECTIVE: The objective of the study was to evaluate once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder (GAD). METHODS: An 11-week (9-week treatment; 2-week posttreatment), randomized, double-blind, placebo-controlled study (D1448C00015) of flexibly-dosed quetiapine XR (50-300 mg/day) or placebo conducted at 47 sites (Estonia, Poland, Russia, Ukraine, and USA) between September 2006 and April 2008. Patients (≥66 years) with DSM-IV diagnosis of GAD, Hamilton Anxiety Rating Scale (HAM-A) total score of ≥20 with item 1 (anxious mood) and 2 (tension) scores of ≥2, Clinical Global Impressions-Severity of Illness (CGI-S) score of ≥4, and Montgomery Åsberg Depression Rating Scale (MADRS) total score of ≤16 were eligible for inclusion. Primary endpoint: week 9 change from randomization in HAM-A total score. RESULTS: Patients were randomized to quetiapine XR (n = 223) or placebo (n = 227). At week 9, quetiapine XR significantly reduced HAM-A total score versus placebo (least squares mean -14.97 versus -7.21; p < 0.001); symptom improvement with quetiapine XR versus placebo was significant at week 1 (p < 0.001). At week 9, quetiapine XR demonstrated significant benefits over placebo for HAM-A response and remission rates, HAM-A psychic and somatic cluster, MADRS total, CGI-S, Pittsburgh Sleep Quality Index global, pain visual analog scale, and Quality of Life, Enjoyment and Satisfaction Questionnaire short form % maximum total scores and Clinical Global Impressions-Improvement (% patients with a score of 1/2) (all p < 0.001). Adverse events (>5% in either treatment group) included somnolence, dry mouth, dizziness, headache, and nausea. CONCLUSIONS: Quetiapine XR (50-300 mg/day) monotherapy is effective in the short term in improving symptoms of anxiety in older patients with GAD, with symptom improvement seen as early as week 1. Tolerability findings were generally consistent with the known profile of quetiapine. SN - 1099-1166 UR - https://www.unboundmedicine.com/medline/citation/23070803/Double_blind_randomized_study_of_extended_release_quetiapine_fumarate__quetiapine_XR__monotherapy_in_older_patients_with_generalized_anxiety_disorder_ L2 - https://doi.org/10.1002/gps.3867 DB - PRIME DP - Unbound Medicine ER -