An Open-label Study to Assess the Safety and Tolerability of Xanax XR in the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall
研究概览
简要总结
The purpose of this study is to assess the long-term safety and tolerability of alprazolam extended release (XR) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. Efficacy, population pharmacokinetics of alprazolam XR and the relationship between alprazolam XR plasma concentrations and efficacy outcomes will also be evaluated.
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
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must meet one of the following 6 diagnoses: a. A current diagnosis of panic disorder with or without agoraphobia; b. Generalized anxiety disorder with a history of at least one panic attack in the course of their illness; c. Social anxiety disorder (social phobia) with a history of at least one panic attack in the course of their illness; d. Separation anxiety with a history of at least one panic attack in the course of their illness; e. Posttraumatic stress disorder with a history of at least one panic attack in the course of their illness; f. Anxiety not otherwise specified with a history of at least one panic attack in the course of their illness.
- •Educational level, intelligence, or other mental condition in the subject and/or his/her parent(s) are judged by the investigator to be sufficient to permit adequate informed consent/assent to be obtained, and for study procedures to be complied with.
排除标准
- •Current (in the past 6 months) diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence.
- •Current (in the past 3 months) diagnosis of alcohol and/or substance abuse.
- •Primary diagnosis of conduct disorder, oppositional defiant disorder, or Attention Deficit Hyperactivity Disorder.
- •Any current or past history of schizophrenia or psychosis; bipolar disorder or cyclothymia; dementia, delirium or other organic brain disease; an eating disorder; mental retardation, Asperger's disorder, or any other serious developmental disorder.
- •A Childhood Depression Rating Scale, Revised score >35.
研究组 & 干预措施
alprazolam group
干预措施: alprazolam XR (Drug)
结局指标
主要结局
Endpoint change from baseline to Week 24 in Digit Symbol-Coding Test, immediate recall, and delayed recall
时间窗: 24 weeks
Baseline-to-peak Physician's Withdrawal Checklist change score during 6-week taper off alprazolam
时间窗: 6 week taper
The incidence of treatment-emergent adverse event during treatment with alprazolam XR
时间窗: 24 weeks with taper
次要结局
- Endpoint change from baseline to Week 24 in CGI-Severity score(24 weeks)
- Endpoint change from baseline to Week 24 in the Panic Disorder Severity Scale-Adolescent version total and item scores(24 weeks)
- Endpoint (Week 24) Clinical Global Impression (CGI)-Improvement score(24 weeks)
- Descriptive estimates of the persistence of safety events and adverse events at study endpoint(24 weeks with taper)
- Endpoint (Week 24) Pediatric Quality of Life, Enjoyment, and Satisfaction Questionnaire improvement score(24 weeks)