Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder

Phase 3 Completed 450 enrolled AstraZeneca

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder. PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Timeline

Start: 2006-09
Primary completion: 2008-04
Completion: 2008-04

Outcome

Met primary endpoint

paper At week 9, quetiapine XR significantly reduced HAM-A total score versus placebo (least squares mean -14.97 versus -7.21; p < 0.001) PMID 23070803 ↗

Publications

Mezhebovsky I, Magi K, She F, Datto C, Eriksson H. 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. doi: 10.1002/gps.3867. Epub 2012 Oct 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Quetiapine	Small molecule	50 mg	—
Subject	Quetiapine	Small molecule	300 mg	—