NCT00635076终止4 期
A Randomized, Double-blind, Placebo-controlled Study of Continuation Treatment With Xanax XR in the Treatment of Adolescents With a Primary Diagnosis of Panic Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2004年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam
研究概览
简要总结
The purpose of this study is to evaluate the long-term (6-month) efficacy, safety, and tolerability of alprazolam XR in adolescents with panic disorder.
详细描述
Due to recruitment difficulties in this adolescent population, the clinical program for alprazolam XR was cancelled and this study was terminated on 1 September 2004. There were no safety concerns that led to this decision.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of panic disorder with or without agoraphobia based on the Mini-International Neuropsychiatric Interview for Children and Adolescents
- •Subjects with an average of 1) at least one 4-symptom panic attack per week over the last 4 weeks before screening; 2) at least one 4-symptom panic attack per week over the last 4 weeks before baseline; and 3) at least one 4-symptom panic attack in the 7 days prior to baseline
- •To enter Study A6131007, subjects must have completed Study A6131002, had an acceptable tolerability to study drug, and in the clinical judgment of the investigator, could have benefited from continued study treatment.
排除标准
- •Subjects must continue to meet all of the exclusion criteria enumerated in the Acute Efficacy Study (Protocol A6131002) with the following exception: Subjects will be allowed to undergo cognitive-behavioral or other panic-specific therapy and any other psychotherapy (e.g., supportive and/or family therapy) during the expected study period in this study.
研究组 & 干预措施
Placebo group
Placebo Comparator
干预措施: placebo (Other)
Alprazolam XR group
Active Comparator
干预措施: alprazolam XR (Drug)
结局指标
主要结局
Baseline-to-peak Physician Withdrawal Checklist change score during taper off Alprazolam
时间窗: Week 24 (taper baseline), Weeks 25-29, and end of taper visit
The incidence of treatment-emergent adverse events during 6 months of treatment with alprazolam XR
时间窗: Weeks 6, 8, 12, 16, 20, and 24
Endpoint change from baseline in Digit Symbol-Coding Test, immediate recall, and delayed recall
时间窗: Week 24
次要结局
- Endpoint change from baseline in Hamilton Anxiety Rating scale(Weeks 12 and 24)
- Endpoint compared with baseline for Clinical Global Impression (CGI)-Improvement scale(Weeks 12 and 24)
- Endpoint change compared with baseline in the Panic Disorder Severity Scale - Adolescent Version total and item scores(Weeks 12 an 24)
- Endpoint change compared with baseline in CGI-Severity score(Weeks 12 and 24)
- Endpoint compared with baseline in Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score(Weeks 12 and 24)
- Descriptive estimates of the persistence of safety events and adverse events(Week 24)
研究者
研究点 (1)
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