Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder

Summary

The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Timeline

Start

2006-04

Primary completion

—

Completion

2007-09

Publications

• Montgomery SA, Locklear JC, Svedsater H, Eriksson H. Efficacy of once-daily extended release quetiapine fumarate in patients with different levels of severity of generalized anxiety disorder. Int Clin Psychopharmacol. 2014 Sep;29(5):252-62. doi: 10.1097/YIC.0000000000000026.
• Stein DJ, Bandelow B, Merideth C, Olausson B, Szamosi J, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies. Hum Psychopharmacol. 2011 Dec;26(8):614-28. doi: 10.1002/hup.1256. Epub 2011 Dec 6.
• Merideth C, Cutler AJ, She F, Eriksson H. Efficacy and tolerability of extended release quetiapine fumarate monotherapy in the acute treatment of generalized anxiety disorder: a randomized, placebo controlled and active-controlled study. Int Clin Psychopharmacol. 2012 Jan;27(1):40-54. doi: 10.1097/YIC.0b013e32834d9f49.

Drugs

Indications