A Double Blind, Randomized, Placebo Controlled, Multicenter Study Examining the Efficacy and Safety of SEP-225441 in Subjects With Generalized Anxiety Disorder.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 456
- 试验地点
- 44
- 主要终点
- Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater
研究概览
简要总结
To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).
详细描述
This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects must be between 18 and 50 years of age
- •Subjects must have GAD
- •Subjects must be in otherwise good general health
排除标准
- •Subject has a documented history of HIV, hepatitis B or hepatitis C.
- •Subject has a recent history (within 6 months of study entry) or current diagnosis of Major Depressive Disorder, panic disorder (or 3 or more panic attacks in the past month). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, or other disorder.
- •Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), any psychotic, bipolar or schizophrenic disorder.
- •Subject has presence or history of antisocial personality or other severe disorder
- •Subject has refractory GAD (previously unresponsive to 2 or more adequate courses of SSRI, SNRI, benzodiazepine or non-benzodiazepine treatment for GAD).
- •Subject has history of seizures, including febrile seizures.
- •Subject has initiated psychotherapeutic intervention with 30 days; however, continued psychotherapy is allowed if stable and not specifically directed at GAD.
- •Subject is undergoing or has undergone electroconvulsive therapy.
- •Subject is a current smoker or has smoked within the last 12 months.
- •Subject has donated blood within the past 30 days or plans to donate during and within 30 days after study participation.
研究组 & 干预措施
1
SEP-225441 (eszopiclone) total daily dose of 1.5 mg
干预措施: eszopiclone (Drug)
2
SEP-225441 (eszopiclone) total daily dose of 0.9 mg
干预措施: eszopiclone (Drug)
3
Placebo total daily dose 0.9 mg
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater
时间窗: Baseline to Week 8
THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
次要结局
- Change From Baseline in Clinician Global Impression of Severity (CGI-S)(Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF))
- Hamilton Anxiety Scale (HAM-A) Remission(Week 2, 4, 6, 8 based on last observation carried forward (LOCF))
- Change in Individual Item Scores on HAM-A(Baseline, Weeks 2, 4, 6, 8)
- Change From Baseline Sheehan Disability Scale (SDS)(Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF))
- Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8)(Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF))
- Change From Baseline Epworth Sleepiness Scale (ESS)(Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF))
- Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response(Week 2, 4, 6, 8)
- Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form(Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF))
- Clinical Global Impression- Improvement (CGI-I)(Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF))
- Change From Baseline Insomnia Severity Index (ISI) Total Score(Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF))