Clinical trial NCT00314210: Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients.
Official title: A Multi-Centre,Double-Blind,Randomised-Withdrawal,Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine SR as Monotherapy in the Maintenance Treatment of Patients With GAD Following an Open-Label Stabilisation Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorders
Keywords: Generalised Anxiety Disorder
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-13
Enrollment: 575
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 primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised anxiety disorder (GAD).

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:

* Patients will be male or female, 18 to 65 years of age (inclusive), with a diagnosis of GAD according to DSM-IV criteria 300.02 as assessed by the MINI.

Exclusion Criteria:

* Patients suffering from depressive symptoms, defined as having a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 17 or more at the enrolment visit, will be excluded from participation in this study.

Primary outcomes:
measure: Time from randomisation to occurrence of an anxiety event
Secondary outcomes:
measure: Occurrence of an anxiety event
measure: Change from randomisation in HAM-A/CGI-S scores
measure: In HAM-A psychic/somatic anxiety factor scores
measure: In MADRS total score and in MADRS item 10 score (suicidal thought)
measure: Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Fresno
country: United States
facility: Research Site
state: California
city: La Mesa
country: United States
facility: Research Site
state: California
city: Oceanside
country: United States
facility: Research Site
state: California
city: Redlands
country: United States
facility: Research Site
state: California
city: Coral Springs
country: United States
facility: Research Site
state: Florida
city: Deland
country: United States
facility: Research Site
state: Florida
city: Ft Myers
country: United States
facility: Research Site
state: Florida
city: Gainsville
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: North Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: St Petersberg
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Columbus
country: United States
facility: Research Site
state: Georgia
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Roswell
country: United States
facility: Research Site
state: Georgia
city: Coeur D'alene
country: United States
facility: Research Site
state: Idaho
city: Hoffman Estates
country: United States
facility: Research Site
state: Illinois
city: Libertyville
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Lafayette
country: United States
facility: Research Site
state: Indiana
city: Valparaiso
country: United States
facility: Research Site
state: Indiana
city: Prairie Village
country: United States
facility: Research Site
state: Kansas
city: Owensboro
country: United States
facility: Research Site
state: Kentucky
city: Paducah
country: United States
facility: Research Site
state: Kentucky
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Glen Burnie
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Cambridge
country: United States
facility: Research Site
state: Massachusetts
city: Pittsfield
country: United States
facility: Research Site
state: Massachusetts
city: St Charles
country: United States
facility: Research Site
state: Missouri
city: Piscataway
country: United States
facility: Research Site
state: New Jersey
city: Bronx
country: United States
facility: Research Site
state: New York
city: Cedarhurst
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Avon Lake
country: United States
facility: Research Site
state: Ohio
city: Beechwood
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Middleburg Heights
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: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Havertown
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: N. Charleston
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Desoto
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Wichita Falls
country: United States
facility: Research Site
state: Texas
city: Midvale
country: United States
facility: Research Site
state: Utah
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Everton Park
country: Australia
facility: Research Site
state: Queensland
city: West Burleigh
country: Australia
facility: Research Site
state: Queensland
city: Malvern
country: Australia
facility: Research Site
state: Victoria
city: Prahran
country: Australia
facility: Research Site
state: Victoria
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Bathurst
country: Canada
facility: Research Site
state: New Brunswick
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Orleans
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Research Site
state: Ontario
city: Gatineau
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Helsinki
country: Finland
facility: Research Site
city: Joensuu
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Pori
country: Finland
facility: Research Site
city: Seinajoki
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Gottingen
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Naumburg
country: Germany
facility: Research Site
city: Nurnberg
country: Germany
facility: Research Site
city: Schwerin
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Balassagyarmat
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Kecskemét
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Bandung
country: Indonesia
facility: Research Site
state: West Java
city: Jakarta
country: Indonesia
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Davao City
country: Philippines
facility: Research Site
city: Mandaluyong City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
state: Berkshire
city: Crawley
country: United Kingdom
facility: Research Site
state: West Sussex
city: Blackpool
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Chorley
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Hamilton
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Martin Brecher, MD
role: STUDY_DIRECTOR
References:
citation: Sheehan DV, Svedsater H, Locklear JC, Eriksson H. Effects of extended-release quetiapine fumarate on long-term functioning and sleep quality in patients with Generalized Anxiety Disorder (GAD): data from a randomized-withdrawal, placebo-controlled maintenance study. J Affect Disord. 2013 Dec;151(3):906-13. doi: 10.1016/j.jad.2013.07.037. Epub 2013 Aug 16.