Prevention of Cigarette Smoking in ADHD Youth With Concerta
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Cigarette Smoking
研究概览
简要总结
This study will consist of a six-week open-label treatment period with an extended duration methylphenidate (OROS MPH) followed by subsequent monthly visits for 24 months in a large sample of youths aged 12-17 who meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD.
The researchers hypothesize that OROS MPH treatment will be associated with low rates of cigarette smoking in ADHD youth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent outpatients between 12 to 17 years of age (inclusive).
- •Subjects with the DSM-IV diagnosis of ADHD, as manifested in the clinical evaluation and confirmed by structured interview.
- •Subjects with sufficient current ADHD symptoms to warrant treatment, as measured by a Clinical Global Impression Severity Scale (CGI-S) score of greater than or equal to 4 (moderately ill); OR subjects already on Concerta who are judged to be responders (CGI of 1 or 2) and who tolerate treatment well.
排除标准
- •Any serious or unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, hypertension), endocrinologic, neurologic, immunologic, or hematologic disease.
- •Clinically significant abnormal baseline laboratory values
- •History of seizures
- •Active tic disorder
- •Pregnant or nursing females
- •Mental retardation (intelligence quotient [IQ] < 75)
- •Organic brain disorder
- •Eating disorders
- •Current bipolar disorder (current episode)
- •Current depression > mild (CGI-S > 3)
- •Current anxiety > mild (CGI-S > 3)
- •Substance abuse or dependence within the past 2 months
- •Recent change in non-monoamine oxidase inhibitor (MAOI) antidepressants (< 3 months)
- •Recent change in benzodiazepines (< 3 months)
- •Concerta non-responder
研究组 & 干预措施
OROS MPH
Single arm- open treatment with extended duration methylphenidate (OROS MPH)
干预措施: methylphenidate HCl (Concerta) (Drug)
结局指标
主要结局
Cigarette Smoking
时间窗: 24 months
Cigarette smoking was assessed by youth self report using a modified version of the Fagerstrom Tolerance Questionnaire (FTQ)
次要结局
未报告次要终点
研究者
Joseph Biederman, MD
Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD
Massachusetts General Hospital