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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 66 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Quetapine XR
Tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily.
干预措施: Quetiapine XR (Drug)
Placebo
Matching placebo tablets orally administered once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
时间窗: Randomization to Week 9
HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization
次要结局
- Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score(Randomization to Week 9)
- Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score(Randomization to Week 9)
- Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score(Randomization to Week 9)
- Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score(Randomization to Week 9)
- Hamilton Rating Scale for Anxiety (HAM-A) Response.(Week 9)
- Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission(Week 9)
- Change in Montgomery-Asberg Depression Rating Scale (MADRS)(Randomization to week 9)
- Change in the Visual Analogue Scale (VAS) Measuring Pain(Randomization to week 9)
- Safety and Well Tolerated as Measured in Adverse Event(From the start of treatment to last dose plus 30 days)
- Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)(From start of the study teatment to last dose plus 30 days)