Clinical trial NCT00329446: Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo & Active Control in Generalized Anxiety Disorder
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Keywords: GAD
anxiety
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patient has a documented clinical diagnosis of Generalized Anxiety Disorder.
* Be able to understand and comply with the requirements of the study.
* Able to understand and provide written informed consent

Exclusion Criteria:

* Patients (female) must not be pregnant or lactating
* Current or past diagnosis of stroke or transient ischemic attack (TIA).

Primary outcomes:
measure: Change from randomization in the HAM-A total score at Day 57
Secondary outcomes:
measure: Change from randomization in CGI-S score at Day 57
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Burbank
country: United States
facility: Research Site
state: California
city: La Mesa
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: Pasadena
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Sherman Oaks
country: United States
facility: Research Site
state: California
city: Upland
country: United States
facility: Research Site
state: California
city: Wildomar
country: United States
facility: Research Site
state: California
city: New Britain
country: United States
facility: Research Site
state: Connecticut
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Bradenton
country: United States
facility: Research Site
state: Florida
city: Deland
country: United States
facility: Research Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Research Site
state: Florida
city: Ft Myers
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Maitland
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Edwardsville
country: United States
facility: Research Site
state: Illinois
city: Merrillville
country: United States
facility: Research Site
state: Indiana
city: Terre Haute
country: United States
facility: Research Site
state: Indiana
city: Newton
country: United States
facility: Research Site
state: Kansas
city: Prairie Village
country: United States
facility: Research Site
state: Kansas
city: Owensboro
country: United States
facility: Research Site
state: Kentucky
city: Lake Charles
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Haverhill
country: United States
facility: Research Site
state: Massachusetts
city: Okemos
country: United States
facility: Research Site
state: Michigan
city: St. Paul
country: United States
facility: Research Site
state: Minnesota
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Kenilworth
country: United States
facility: Research Site
state: New Jersey
city: Princeton
country: United States
facility: Research Site
state: New Jersey
city: Toms River
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: New York City
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Salem
country: United States
facility: Research Site
state: Oregon
city: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Columbia
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Kirkland
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Morgantown
country: United States
facility: Research Site
state: West Virginia
Study officials:
affiliation: AstraZeneca
name: Anders Neijber, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.