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临床试验/NCT00931398
NCT00931398撤回4 期

Treatment of College Students With ADHD Using OROS Methylphenidate

University of Pittsburgh1 个研究点 分布在 1 个国家开始时间: 2010年4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
撤回
试验地点
1
主要终点
The primary efficacy measures will be the self-reported CAARS DSM-IV ADHD Symptoms Total and the CAARS Inattention/Memory Problems indices (Connors et al., 1999)

研究概览

简要总结

The purpose of the proposed study is to determine the effectiveness of methylphenidate HCl (Concerta) in college students with ADHD. This study will consist of 110 college students between the ages of 18 and 25 who are enrolled full-time in a local or junior college. The study consists of an 8-week double-blind, placebo-controlled trial of placebo versus methylphenidate HCl (Concerta®) followed by a 10-week extension of open label methylphenidate HCl (Concerta®).

详细描述

There are very few trials on drug efficacy and safety treatment performed specifically for college students with Attention-Deficit/Hyperactivity Disorder (ADHD). Although data based on the adult population can often be extrapolated and generalized to a college population, there are unique treatment demands for college students with ADHD that are not represented in day-to-day functioning of adults with ADHD. For example, although adults may be able to choose employment that capitalizes on their skill sets and tolerate ADHD-related deficits, all college students must manage intensive learning experiences in an environment that places unparalleled demands on higher order cognitive processes that are deficient with ADHD. In addition, it may be important to address the comorbidities that may be common among ADHD college students. This could range from eating disorders, depression or anxiety to alcoholism and drug abuse. For example, heavy drinking peaks in the college student years regardless of ADHD but the long-term course and underlying predispositions may be different among individuals with a history of ADHD (Molina et al., 2007). Although there are a few case studies, there are limited studies on ADHD and their comorbidities in college students perhaps because it may be a challenge to recruit a respectable sample size. Furthermore, it may be important to recognize that some college students never develop diagnosable ADHD symptoms as children, and that the signs may manifest themselves in a very harmful way during college when demands for academic rigor and organization reach their height. Given the juxtaposing conditions of academic demand, autonomy from parents, and increased opportunities for drug abuse, it becomes imperative to directly address treatment in this population. Much more research is left to be performed on this unique population of ADHD patients.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18-25 years, inclusive
  • DSM-IV diagnosis of ADHD (any subtype)
  • Clinical Global Impressions scale (CGI)-Severity score of ≥4 ("Moderately ill" or higher) for ADHD

排除标准

  • Pregnancy or a history of seizure disorder, other neurological or medical disorder for which medication treatment may present a considerable risk
  • Abnormal liver function
  • History of pervasive developmental disorder, schizophrenia, other psychotic disorders, or eating disorders
  • Currently taking other psychotropic medications from which discontinuation would present a significant risk (we will not allow subjects with a satisfactory medication response to discontinue that medication and to participate)
  • Active substance dependence or lack of control of substance use that does not allow for safe medication administration

研究组 & 干预措施

Methylphenidate HCl (Concerta)

Experimental

干预措施: methylphenidate HCl (Concerta) (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

The primary efficacy measures will be the self-reported CAARS DSM-IV ADHD Symptoms Total and the CAARS Inattention/Memory Problems indices (Connors et al., 1999)

时间窗: 8 weeks

次要结局

  • Secondary measures include CAARS subscales, Barkley Adult ADHD Rating Scale, Impairment Rating Scale, General Life Functioning, final grades and GPA, substance use and associated negative consequences.(8 weeks)

研究者

申办方类型
Other

研究点 (1)

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