A Multicenter, Rand., Double-blind, Parallel-group, Pbo-controlled Study of the Efficacy and Safety of SEROQUEL® XR Compared With Pbo as an Adjunct to Treatment in Patients With Generalized Anxiety Disorder Who Demonstrate Partial or No Response to a SSRI or SNRI Alone or in Combination With a Benzo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 409
- 试验地点
- 1
- 主要终点
- Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
研究概览
简要总结
This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of Informed Consent
- •Documented diagnosis of Generalized Anxiety Disorder
- •Female patients must not be pregnant and be willing to use a reliable method of birth control
- •Be able to understand and comply with study requirements
排除标准
- •Other psychiatric disorders that could confound the study results, as judged by the study doctor
- •Moderate to severe depression
- •Other clinically relevant diseases, as judged by the study doctor
- •Medication that you are taking, as judged by the study doctor
研究组 & 干预措施
1
Adjunctive Placebo Seroquel XR to anxiety treatment
干预措施: Placebo (Drug)
2
Adjunctive Seroquel XR to anxiety treatment
干预措施: quetiapine fumarate XR (Drug)
结局指标
主要结局
Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
时间窗: Baseline (randomization) and then 8 weeks
Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.
次要结局
- Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score(Baseline (randomization) and then 8 weeks)
- Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score(Baseline (randomization) and then 8 weeks)
- Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score(Baseline (randomization) and then 8 weeks)
- Least Square Mean Change From Randomization to Week 1 in CGI-S Score(Baseline (randomization) and then 8 weeks)
- Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score(Baseline (randomization) and then 8 weeks)
- Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score(Baseline (randomization) and then 8 weeks)
- Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8(Baseline (randomization) and then 8 weeks)
- Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score(Baseline (randomization) and then 8 weeks)
- Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8(Baseline (randomization) and then 8 weeks)
- Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8(Baseline (randomization) and then 8 weeks)
- Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score(Baseline (randomization) and then 8 weeks)
- Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1(Baseline (randomization) and then 8 weeks)
- Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score(Baseline (randomization) and then 8 weeks)
- Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score(Baseline (randomization) and then 8 weeks)