Adult Normative Performance on Quotient ADHD System - Adolescent and Adult Version (Ages 15-55 Years Old)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Well-screened, Non-ADHD Controls to Augment the Existing Adolescent and Adult Database Thus Expanding the Normative Reference Range of Performance of the Quotient® Adolescent and Adult Version Test.
研究概览
简要总结
This study is being conducted to enhance and extend the clinical utility of the Quotient® ADHD System Adolescent and Adult Version Test by adding large numbers of well-screened controls to the existing Quotient® ADHD System database of adolescents and adults (ages 15-55).
详细描述
This study consists of one study visit. Subjects will be recruited using the clinic's relevant patient population. A "Study Recruitment Flyer" will also be posted in various clinic locations (Attachment BBD0111-1). Interested volunteers will participate in an initial screening, which may be done by telephone or in person that will be conducted by the clinic's research staff. Upon preliminary confirmation that the subject meets all inclusion criteria and does not meet any exclusion criteria, an appointment will be scheduled for the study visit.
At the study visit, study will be explained in detail. Adults will be asked to provide written informed consent, parents/guardians of individuals <18 year old will provide written informed consent and minor individual's will provide written assent, prior to any study procedure being performed.
Following consent, a medical history, including current medications the subject is taking, will be obtained. Subjects will complete standard self assessment questionnaires to screen for presence of mental health issues including ADHD, anxiety disorder, depressive disorder or bipolar disorder using the ADHD Self Rating Scale (ASRS), Zung Self-Rated Anxiety Scale (SAS), Zung Self-Rated Depression Scale (SDS), and Mood Disorder Questionnaire (MDQ).
Subjects will not be excluded from the study based on responses to the mental health questionnaires, but results will be considered in the analysis of results.
The subjects will take the 20-minute Quotient® ADHD System Test for Adolescent and Adult assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible for enrollment if they fulfill the following inclusion criteria:
- •Male or Female
- •Ages 15 to 55
- •Un-medicated with medications known to affect ADHD or cognitive functioning
- •Report of good physical health
- •Able to understand test instructions and comply with testing
- •Willing to give written informed consent and/or assent
排除标准
- •History of diagnosis of ADHD
- •History of known neurological disease or insult (e.g., head trauma with LOC, skull fracture, past or present migraine headaches, seizure disorders)
- •Major Medical Disorders
- •Past/present alcohol or substance abuse or dependence
- •Current or past DSM-IV disorder, screened by the computerized SCID I & II, and reviewed by investigator
- •Any major medical or neurological condition that could affect motor activity or attention (e.g. Parkinson's, MS, dementia)
- •Currently ill with cold/flu/infections which may compromise their ability to perform the computer task
结局指标
主要结局
Well-screened, Non-ADHD Controls to Augment the Existing Adolescent and Adult Database Thus Expanding the Normative Reference Range of Performance of the Quotient® Adolescent and Adult Version Test.
时间窗: 12 to 18 weeks
To increase the number of "normal" Adolescent and Adult tests to the existing Quotient System Database. To assure subjects are "normal", participants will complete a standard battery of self assessment questionnaires to screen for the presence of mental health issues including: ADHD, Anxiety Disorder, Depressive Disorder or Bipolar Disorder using the following well established scales and their scoring guidelines: 1. ADHD Self Rating Scale (ASRS) 2. Zung Self-Rated Anxiety Scale (SAS) 3. Zung Self-Rated Depression Scale (SDS) 4. Mood Disorder Questionnaire (MDQ) 5. Quotient® ADHD System Test, Adolescent and version Each subject and their individual assessment scores will be evaluated by a physician. Those participants evaluated as "normal"(without ADHD) will have the results of their Quotient test added to the existing Quotient normative database of Non ADHD subjects.
次要结局
未报告次要终点