Clinical trial NCT00389064: Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder
Official title: A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients With Generalised Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety Disorders
Keywords: Generalised Anxiety Disorder
GAD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-18
Enrollment: 450
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male or female patients, 66 years or older, with a documented clinical diagnosis of Generalised Anxiety Disorder (GAD).
* Absence of current episode of major depression.

Exclusion Criteria:

* The presence of dementia or other mental disorder than GAD.
* Serious suicidal risk, uncontrolled hypertension, substance or alcohol abuse.
* A current diagnosis of cancer or current or past diagnosis of stroke.

Primary outcomes:
measure: Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
timeFrame: Randomization to Week 9
Secondary outcomes:
measure: Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score
timeFrame: Randomization to Week 9
measure: Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
timeFrame: Randomization to Week 9
measure: Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
timeFrame: Randomization to Week 9
measure: Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
timeFrame: Randomization to Week 9
measure: Hamilton Rating Scale for Anxiety (HAM-A) Response.
timeFrame: Week 9
measure: Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission
timeFrame: Week 9
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Randomization to week 9
measure: Change in the Visual Analogue Scale (VAS) Measuring Pain
timeFrame: Randomization to week 9
measure: Safety and Well Tolerated as Measured in Adverse Event
timeFrame: From the start of treatment to last dose plus 30 days
measure: Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)
timeFrame: From start of the study teatment to last dose plus 30 days
Other outcomes:
Locations:
city: Ft Myers
country: United States
facility: Research Site
state: Florida
city: Gainsville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Roswell
country: United States
facility: Research Site
state: Georgia
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Bronx
country: United States
facility: Research Site
state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Avon Lake
country: United States
facility: Research Site
state: Ohio
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Jenkintown
country: United States
facility: Research Site
state: Pennsylvania
city: Austin
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: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Viljandi
country: Estonia
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Gorlice
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Leszno
country: Poland
facility: Research Site
city: Skorzewo
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Lipetsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: St-petersburg
country: Russian Federation
facility: Research Site
city: Stavropol
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Glevakha
country: Ukraine
facility: Research Site
state: Kiev Region
city: Dnepropetrovsk
country: Ukraine
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Lugansk
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Vinnitsa
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Ricardo Ruiz, MD
role: STUDY_DIRECTOR
References:
citation: 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.