Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder - Full Text View

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00389064

Purpose

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.

Condition	Intervention	Phase
Anxiety Disorders	Drug: Quetiapine XR Drug: Placebo	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: Randomization to Week 9 ] [ Designated as safety issue: No ]
HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization

Secondary Outcome Measures:

Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score [ Time Frame: Randomization to Week 9 ] [ Designated as safety issue: No ]
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
Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score [ Time Frame: Randomization to Week 9 ] [ Designated as safety issue: No ]
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
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score [ Time Frame: Randomization to Week 9 ] [ Designated as safety issue: No ]
HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score [ Time Frame: Randomization to Week 9 ] [ Designated as safety issue: No ]
HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization
Hamilton Rating Scale for Anxiety (HAM-A) Response. [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.
Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
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
Change in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Randomization to week 9 ] [ Designated as safety issue: No ]
MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization
Change in the Visual Analogue Scale (VAS) Measuring Pain [ Time Frame: Randomization to week 9 ] [ Designated as safety issue: No ]
Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization
Safety and Well Tolerated as Measured in Adverse Event [ Time Frame: From the start of treatment to last dose plus 30 days ] [ Designated as safety issue: Yes ]
Number of patients have at least one adverse event
Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS) [ Time Frame: From start of the study teatment to last dose plus 30 days ] [ Designated as safety issue: Yes ]
Number of patients have adverse events associated with EPS

Enrollment:	450
Study Start Date:	September 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Quetapine XR Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.	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 Comparator: Placebo Matching placebo tablets orally administered once daily.	Drug: 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.

Eligibility

Ages Eligible for Study:	66 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389064

Show 43 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Ricardo Ruiz, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00389064 History of Changes
Other Study ID Numbers:	D1448C00015, EUDRACT No: 2006-001195-21
Study First Received:	October 17, 2006
Results First Received:	April 15, 2009
Last Updated:	March 30, 2012
Health Authority:	Estonia: The State Agency of Medicine Lithuania: State Medicine Control Agency - Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health and Social Development of the Russian Federation Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by AstraZeneca:

Generalised Anxiety Disorder
GAD

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 24, 2012