Double-blind, randomized study of extended release quetiapine fumarate (quetiapine XR) monotherapy in older patients with generalized anxiety disorder

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...

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Bibliographic Details
Published in:International journal of geriatric psychiatry 2013-06, Vol.28 (6), p.615-625
Main Authors: Mezhebovsky, Irina, Mägi, Kairi, She, Fahua, Datto, Catherine, Eriksson, Hans
Format: Article
Language:English
Subjects:
Aged
Aged, 80 and over
Analysis of Variance
Antipsychotic Agents - administration & dosage
Antipsychotic Agents - adverse effects
Anxiety
Anxiety Disorders - drug therapy
atypical antipsychotic
Delayed-Action Preparations
Dibenzothiazepines - administration & dosage
Dibenzothiazepines - adverse effects
Double-Blind Method
Drug therapy
Female
generalized anxiety disorder
Geriatric psychiatry
Geriatric psychology
Humans
Male
Mental health care
Older people
older population
Patient Satisfaction
Psychotropic drugs
Quality of Life
Quetiapine Fumarate
quetiapine XR
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Summary: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 
ISSN:0885-6230
1099-1166
DOI:10.1002/gps.3867