NCT00299234终止4 期
Atomoxetine for Children With Acquired Attentional Disorders Following Completion of Chemotherapy for Acute Lymphocytic Leukemia
Monarch Medical Research1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2006年6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
- 1
- 试验地点
- 1
- 主要终点
- The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.
研究概览
简要总结
This study is a double-blind, placebo-controlled, parallel group trial of atomoxetine (1.8 mg/kg) for the management of chemotherapy-related acquired attentional disorders in children who have survived Acute Lymphocytic Leukemia. Atomoxetine will produce a favorable impact on ADHD symptoms in children with chemo-related acquired attentional disorders.
详细描述
The primary objective of this study is to assess the safety, tolerability and efficacy of atomoxetine as determined by the change in the ADHD-RS-IV Total score compared to placebo in the symptomatic treatment of patients diagnosed with Attention-Deficit/Hyperactivity Disorder (by DSM-IV ADHD-NOS criteria) occurring as a neuropsychological late-effect of chemotherapy used to treat Acute Lymphocytic Leukemia (ALL).
The secondary objectives are:
- to assess the effect of once daily (AM) dosing of atomoxetine (1.8mg/kg) compared to placebo on ADHD symptoms as measured by:
- ADHD-RS Total score inclusive of subtypes for inattention, hyperactivity and combined subtypes.
- Clinical Global Impression-ADHD
- to evaluate the safety and tolerability of atomoxetine compared with placebo based on treatment-emergent adverse events (AEs), laboratory tests, vital signs, physical examinations, and ECGs.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 6-18 years
- •Must have successfully completed treatment for ALL and are currently 1-year "disease free" as judged by the investigators.
- •Must meet DSM-IV criteria for "ADHD-NOS.( Attachment A) The attention deficit symptoms have been precipitated by chemotherapy-related neurological injury. Therefore, the DSM-IV category is ADHD-NOS.
- •Must have an Investigator-completed ADHD-RS total and/or subscale score of ≥1.5 standard deviations above age/gender norm.
- •Laboratory results, including chemistries, hematology, and urinalysis do not demonstrate clinically significant abnormalities.
- •ECG demonstrates no clinically significant abnormalities
- •Educational level and degree of understanding of the patient and their parents permit suitable communication between the investigators and study coordinators.
- •Subjects and parents are judged to be reliable to keep appointments.
- •Must be able to swallow tablets.
- •Must have demonstrated compliance during their chemotherapy program.
- •Must weigh > 20 kg.
排除标准
- •Have relapsed or are having re-occurring symptoms/signs of ALL.
- •Have had substantial exposure to radiation therapy (>2000: cGy) since high dose radiation treatment is associated with neurocognitive deficits or be "treatment resistant" pharmacologically.
- •Past exposure to atomoxetine.
- •ADHD symptoms or treatment prior to the diagnosis of ALL
- •Documented bipolar disorder, psychosis, affective disorder.
- •Female subjects who are pregnant or breastfeeding.
- •Suicide risk.
- •Seizure disorders (except history of febrile seizures).
- •Histories of multiple drug allergies.
- •Histories of alcohol or substance abuse.
- •Prior or current medical conditions that, in the opinion of the investigators, could be exacerbated by atomoxetine.
- •Sympathomimetic overactivity such as catecholamine secreting tumor.
- •Use of MAOI medications.
- •Have taken psychostimulants one week prior to randomization.
- •Current or past history of hypertension.
研究组 & 干预措施
2
Placebo Comparator
placebo
干预措施: Atomoxetine (Drug)
1
Experimental
atomoxetine
干预措施: Atomoxetine (Drug)
结局指标
主要结局
The primary outcome is the change in the ADHD-RS total score from baseline to completion of the study.
时间窗: 5 weeks
次要结局
- The secondary outcome is the difference in CGI categories by the treatment versus placebo group.(5 weeks)
研究者
研究点 (1)
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