NCT00389064 - Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder | Crick | Crick

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

Phase 3CompletedNCT00389064

AstraZeneca450 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

450

Conditions

Anxiety Disorders

Interventions

Quetiapine XRDRUG

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.

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

Sex: ALLMin age: 66 Years

Medical Language ↔ Plain English

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.

Locations (43)

Outcomes

Primary Outcomes

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

Time frame: Randomization to Week 9

Secondary Outcomes

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

Time frame: Randomization to Week 9

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

Time frame: Randomization to Week 9

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

Time frame: Randomization to Week 9

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

Time frame: Randomization to Week 9

Hamilton Rating Scale for Anxiety (HAM-A) Response.

HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score.

Data from ClinicalTrials.gov

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