An Open Label Pilot Study of Atomoxetine Hydrochloride in Adolescents With Attention Deficit/Hyperactivity Disorder and Comorbid Cannabis Abuse.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks
研究概览
简要总结
The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in adolescents with ADHD and comorbid cannabis abuse.
详细描述
In the past adolescents with cannabis abuse have been excluded from studies in which atomoxetine for ADHD symptoms was studied. In this study the efficacy of atomoxetine on symptoms of ADHD in adolescents with ADHD and comorbid cannabis abuse will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Diagnosis ADHD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
- •At least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHD Rating Scale-IV-Parent Version
- •Cannabis Abuse or dependence based on the DSM-IV-TR, and using a minimum of 5 joints per week
排除标准
- •Weight under 20 kilograms (kg)
- •Patients at serious suicidal risk
- •Patients with alcohol or drug abuse (other than cannabis)
- •Patients who in the investigator's judgement are likely to need psychotropic medication + psychotherapy apart from atomoxetine
研究组 & 干预措施
Atomoxetine
0.5 milligrams per kilogram (mg/kg) daily for 1 week followed by 1.2 mg/kg daily for 11 weeks, orally, capsules.
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale-IV-Parent Version: Investigator Scored Total Score at 12 Weeks
时间窗: 12 weeks
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher scores indicate greater impairment. The scale is scored by an investigator while interviewing the parent.
次要结局
- Clinical Global Impression-ADHD-Improvement (CGI-ADHD-I) at 12 Weeks(12 weeks)
- Change From Baseline to 12 Weeks in Global Impression of Perceived Difficulties (GIPD) - Participant Rated Version(Baseline, 12 weeks)
- Change From Baseline to 12 Weeks in the Children's Depression Rating Scale-Revised (CDRS-R)(Baseline, 12 weeks)
- Change From Baseline to 12 Weeks in the Pediatric Anxiety Rating Scale (PARS)(Baseline, 12 weeks)
- Change From Baseline to 12 Weeks in the Marijuana Craving Questionnaire (MCQ)(Baseline, 12 weeks)
- Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Stop-Signal Task(Baseline, 12 weeks)
- Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Contingency Task(Baseline, 12 weeks)
- Change From Baseline in Neurocognitive Functioning as Measured at 12 Weeks by a Test Battery: Time Reproduction Task(Baseline, 12 weeks)
- C-SSRS Suicidal Ideation By Visit at Week 4: Non-Specific Active Suicidal Thoughts(Week 4)
- C-SSRS Intensity of Ideation (Most Common Ideation Type and Most Severe Ideation Type) By Visit at Week 4(Week 4)