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

Anxiety Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389064
• Other study ID #: D1448C00015
• Secondary ID: EUDRACT No: 2006
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2006
• Last updated: March 30, 2012
• Start date: September 2006
• Est. completion date: April 2008

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: The State Agency of MedicineLithuania: State Medicine Control Agency - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 66 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Drug:
• Quetiapine XR
Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period.
• Placebo
Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.

Locations

Country	Name	City	State
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Estonia	Research Site	Viljandi
Poland	Research Site	Bialystok
Poland	Research Site	Gorlice
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Research Site	Leszno
Poland	Research Site	Skorzewo
Poland	Research Site	Torun
Poland	Research Site	Wroclaw
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Izhevsk
Russian Federation	Research Site	Lipetsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhny Novgorod
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	St-petersburg
Russian Federation	Research Site	Stavropol
Russian Federation	Research Site	Voronezh
Ukraine	Research Site	Dnepropetrovsk
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Glevakha	Kiev Region
Ukraine	Research Site	Kiev
Ukraine	Research Site	Lugansk
Ukraine	Research Site	Odessa
Ukraine	Research Site	Vinnitsa
United States	Research Site	Austin	Texas
United States	Research Site	Avon Lake	Ohio
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bronx	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Eugene	Oregon
United States	Research Site	Ft Myers	Florida
United States	Research Site	Gainsville	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Jenkintown	Pennsylvania
United States	Research Site	Miami	Florida
United States	Research Site	Roswell	Georgia
United States	Research Site	San Antonio	Texas
United States	Research Site	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Estonia,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization	Randomization to Week 9	No
Secondary	Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score	Q-LES-Q total score is the sum of the first 14 items of Q-LES-Q, and this total score is converted to a % maximum total score by : (Q-LES-Q total score -14) /56 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction.; Change : percentage at week 9 minus percentage at randomization	Randomization to Week 9	No
Secondary	Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score	CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best Change : score at week 9 minus score at randomization	Randomization to Week 9	No
Secondary	Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score	HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization	Randomization to Week 9	No
Secondary	Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score	HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization	Randomization to Week 9	No
Secondary	Hamilton Rating Scale for Anxiety (HAM-A) Response.	HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.	Week 9	No
Secondary	Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission	HAM-A remission, defined as HAM-A total score less or equal to 7. An indicator of HAM-A remission is calculated as: If HAM-A total score=7, THEN indicator=1; If HAM-A total score >7, THEN indicator=0	Week 9	No
Secondary	Change in Montgomery-Asberg Depression Rating Scale (MADRS)	MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization	Randomization to week 9	No
Secondary	Change in the Visual Analogue Scale (VAS) Measuring Pain	Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization	Randomization to week 9	No
Secondary	Safety and Well Tolerated as Measured in Adverse Event	Number of patients have at least one adverse event	From the start of treatment to last dose plus 30 days	Yes
Secondary	Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)	Number of patients have adverse events associated with EPS	From start of the study teatment to last dose plus 30 days	Yes

External Links

•   AstraZeneca Clinical Trial Information - Outside US