NCT00585910已完成4 期
Efficacy and Safety/Tolerability of OROS MPH (Concerta) Plus Atomoxetine (ATMX) in Children and Adolescents (Age 6-17) With Attention Deficit Hyperactivity Disorder (ADHD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)
研究概览
简要总结
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients from 6 to 17 years old.
- •Subjects with a DSM-IV diagnosis of ADHD by clinical interview, confirmed by the KSADS-E ADHD module.
- •Subject with DSM-IV diagnosis of ADHD without previous treatment.
- •Subjects with DSM-IV diagnosis of ADHD with a clinical history of a partial response to ATMX or methylphenidate as monotherapy.
- •In phase I, subjects with a CGI-Severity of at least moderate impairment related to their ADHD (CGI >4).
- •In phase II, subjects receiving therapeutic doses of ATMX with at least minor improvement in their clinical picture due to the ATMX as determined operationally (CGI-Improvement score indicating at least minor improvement relative to off-drug baseline) will be included.
- •In phase II, only subjects receiving ATMX that also have evidence of persistent symptoms of ADHD and impairment related to their ADHD (a CGI-Severity of > minor impairment OR ADHD RS >18; AND GAF score <65) will have Concerta added to their regimen.
- •Subjects' parents must provide informed consent and subjects' assent.
排除标准
- •Pregnant or nursing females or females not using proper contraception.
- •Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study.
- •Subjects (or their families) who do not appear to be reliable reporters of their condition or who indicate they will not be able to meet the schedule of visits for the duration of the study.
- •Subjects with Mental Retardation or Organic Brain Syndromes.
- •Subjects who have a lifetime history of a psychotic or bipolar disorder.
- •Subjects with recent or current (past 30 days) major depressive disorder or a clinically significant anxiety disorder that would potentially necessitate treatment during the trial. g. Subjects with recent evidence (past 30 days) of suicidality or homicidality will not be enrolled.
- •Subjects with a recent history (e.g. three months) of a substance use disorder; or those with a positive urine for substances of abuse will not be enrolled. Subjects will be told that a positive urine for substances of abuse will be disclosed to their parents.
- •Subjects taking stimulants or other psychotropics at the time of the evaluation. Subjects will not be discontinued from their current medication regimen (not including ATMX), unless authorized and supervised by their treating physician.
- •Treatment of stimulants within one week of the evaluation; tricyclic antidepressants, bupropion, cholinesterase inhibitors, modafinil, clonidine/guanfacine, lithium/anticonvulsants for behavioral control, or serotonin reuptake inhibitors (except fluoxetine) for four weeks prior to entry are prohibited. Treatment with antipsychotics/neuroleptics and fluoxetine for 8 weeks prior to entry are prohibited.
- •Subjects using any prescribed or over-the-counter concurrent treatment for ADHD.
- •Subjects with a history of a lack of response to either ATMX or methylphenidate.
- •Subjects with a history of a serious adverse event to either ATMX or methylphenidate.
研究组 & 干预措施
1
Experimental
Total treatment period is 7 weeks. Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate will then be added to his or her treatment regimen for the final 3 weeks of the study.
干预措施: Atomoxetine and OROS Methylphenidate (Drug)
结局指标
主要结局
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS)
时间窗: 7 weeks
The primary outcome was the ADHD rating scale. Change scores for the ADHD Rating Scale (RS), from baseline to endpoint (week 7 or last observation carried forward), were analyzed with paired t-tests and nonparametric Wilcoxon sign-rank tests. The best score is a score of 0 (no ADHD symptoms) and the worst score is the highest score possible (54).
次要结局
- Clinical Global Impressions - Level of Severity (CGIs) for ADHD and Other Psychiatric Disorders(7 weeks)
研究者
Timothy Wilens, MD
MD
Massachusetts General Hospital
研究点 (1)
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