Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 615
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1
研究概览
简要总结
The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis Generalized Anxiety Disorder
- •HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline
- •Needs pharmacological treatment
排除标准
- •Current or past diagnosis of any other DSM IV Axis I disorders
- •A history of failed treatment with a benzodiazepine
- •Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder
研究组 & 干预措施
1
干预措施: Pregabalin (Drug)
2
干预措施: Lorazepam (Drug)
3
干预措施: Pregabalin (Drug)
4
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1
时间窗: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2
时间窗: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1
时间窗: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2
时间窗: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1
时间窗: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2
时间窗: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1
时间窗: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2
时间窗: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1
时间窗: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2
时间窗: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1
时间窗: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2
时间窗: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
次要结局
- Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2(Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24))
- Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9))
- Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24))
- Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2(Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9))
- Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2(Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2(Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24))
- Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9))
- Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit)(Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24))
- Hamilton Anxiety Scale (HAM-A) Score for Period 1(Baseline, Week 12)
- Hamilton Anxiety Scale (HAM-A) Score for Period 2(Baseline, Week 24)
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12(Baseline, Week 12)
- Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24(Baseline, Week 24)
- Clinical Global Impression - Severity (CGI-S) Score for Period 1(Baseline, Week 12)
- Clinical Global Impression - Severity (CGI-S) Score for Period 2(Baseline, Week 24)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12(Baseline, Week 12)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24(Baseline, Week 24)
- Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1(Week 12)
- Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2(Week 24)
- Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9))
- Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2(Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24))
- Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9))
- Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15))
- Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit)(2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24))
- Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2(Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9))