An 8-Week, Double-Blind, Placebo-Controlled, Phase 3 Trial of Pregabalin (150-600 mg/Day) in the Adjunctive Treatment of Patients With Generalized Anxiety Disorder (GAD) Who Have Not Optimally Responded to Existing Therapies(GAD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from baseline observed following 8 weeks of double-blind treatment or at earlier termination during the double-blind treatment phase and analyzed using a mixed linear model for repeated measures.
详细描述
Further enrollment in this study was stopped on January 28, 2008 based on the recommendation of an independent data monitoring committee. The recommendation to stop the study was not based on any safety findings.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female subjects with primary DSM-IV diagnosis of GAD, as confirmed by the MINI structured interview.
- •Historical failure to respond optimally to a GAD treatment
排除标准
- •Current primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th edition) diagnosis of major depressive disorder with or without seasonal pattern, dysthmic disorder, depressive disorder NOS (not otherwise specified), social phobia, panic disorder with or without agoraphobia, post traumatic stress disorder, dissociative disorder, borderline personality disorder, obsessive-compulsive disorder, antisocial personality disorder, as defined in the DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text Revision).
- •Past and/or current DSM-IV diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder).
研究组 & 干预措施
Arm 2
干预措施: placebo (Drug)
Arm 1
干预措施: pregabalin (Drug)
结局指标
主要结局
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores
时间窗: Baseline, 8 weeks
Change from baseline: average across visit weeks using mixed model. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, \& restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.
次要结局
- Change in HAM-A Total Score at Weekly Visits(Baseline, Weeks 1 through Week 8)
- Number of Responders Using Hamilton Anxiety Rating Scale (HAM-A)(Weeks 1 through Week 8)
- Subjects in Remission Using Hamilton Anxiety Rating Scale (HAM-A) Total Score(Week 1 through Week 8)
- Time to Onset of Sustained Hamilton Anxiety Rating Scale (HAM-A) Improvement(Week 8)
- Number of Responders Using Clinical Global Impression of Improvement (CGI-I) Score(Week 1 through Week 8)
- Clinical Global Impression of Severity (CGI-S) Score(Week 8)
- Change in Hamilton Depression Rating Scale (HAM-D) Total Score(Weeks 1 through Week 8)