Assessment of Pharmacogenomics Testing for Improving Pediatric ADHD Psychopharmacological Treatment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Assessment of Change in ADHD Symptom Severity Between Experimental and Control Group
研究概览
简要总结
This research study is a randomized controlled trial (RCT) to test whether pharmacogenomics (PGx) testing for ADHD medications will help guide clinicians to choose medications and dosages for pediatric ADHD treatment that provide faster symptom relief, fewer or less severe side effects, improve patient quality of life, and lessen emotional stress for parents/guardians of the patients.
详细描述
The study is a randomized controlled trial (RCT) of pediatric Attention Deficit Hyperactivity Disorder (ADHD) patients using an experimental group and a control group. The subjects in the experimental group will be administered a commercially available pharmacogenomics (PGx) test panel of 38 genes specifically related to drug metabolism rates and drug response. A subset of these genes are known to be involved in the pharmacokinetics and pharmacodynamics of ADHD medications.
The PGx test report indicates if there are genetic variants detected related to ADHD medications and consequently provides recommendations for the clinician on which medications and doses may be optimally effective. The control group is the "treatment as usual" (TAU) group whose subjects are treated with medications for ADHD based on the treating clinician's customary method(s) for selecting medications and doses.
The hypotheses to be tested are that PGx testing guidance will reduce the time it takes to reach a treatment regimen that improves patient symptom relief, reduces the frequency and severity of adverse drug reactions, improves patient quality of life, and reduces parental emotional stress. Additionally, since the test is performed using next-generation sequencing, we wish to tabulate relevant allele frequencies and use variant call files to discover previously unknown PGx genetic variants.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects will be blinded as to study arm participation and outcome assessments.
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
- •Male or female between the ages of 6 and 18 inclusive at the start of the study.
- •Provision of signed and dated informed consent form.
- •Subject and parent or legal guardian must state willingness to comply with all study procedures and availability for the duration of the study.
- •Both male and female subjects will be recruited from the pediatric population diagnosed with any subtype of ADHD without Oppositional Defiant Disorder (ODD) via the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria.
- •Subject and their parent or legal guardian will read and speak English with sufficient proficiency to understand the study and be able to give informed assent and consent.
- •Subject will be able to complete study procedures such as filling out paper quality of life assessments
- •Subjects will be able to take oral medication(s) if and as prescribed.
- •Agreement to adhere to Lifestyle Considerations throughout study duration.
排除标准
- •Subjects will not have been treated for any condition with psychiatric prescription medications within the previous six (6) months.
- •Subjects will not have had a diagnosis of Oppositional Defiant Disorder (ODD).
- •Subject will not be currently a suicide risk, has previously made a suicide attempt or has a prior history of suicidal behavior.
- •Subject will not have a history of alcohol or other substance abuse or dependence within the last 6 months.
- •Subject will not have used an investigational medicinal product or participation in a clinical study within six (6) months prior to the baseline visit.
- •Subject will not have a clinically important abnormality on urine drug and alcohol screen, if one had been taken.
- •If the subject is female, is not currently pregnant, reasonably expecting to become pregnant, or lactating.
- •Subject will not have a known or suspected allergy to any of the potential medications that may be prescribed.
- •Only one subject per family will be enrolled to prevent systematic bias based on a parent or legal guardian's personal style of symptom assessment.
结局指标
主要结局
Assessment of Change in ADHD Symptom Severity Between Experimental and Control Group
时间窗: At baseline and at 24 weeks
Measurement is performed by using the National Institute for Children's Health Quality (NICHQ) Vanderbilt Assessment Scales. The Vanderbilt assessment for ADHD is a validated questionnaire that provides a quantitative measure of ADHD symptoms and severity. Specific measures: Symptom Score: 18 questions on symptom type and severity between a measure of 0 (Never) and 3 (Very Often). Total Symptom Score range from 0 to 54. Lower scores indicate less severe symptoms. Performance Score: 8 questions on subject academic and interpersonal relationship functions using a measure between 1 (Excellent) and 5 (Problematic). Performance Score ranges from 0 to 40. Lower scores indicate better performance. Side Effects or Problems: 12 questions related to health and behavioral issues. Scores range from None, Mild, Moderate, to Severe. These are not quantitatively scored on the assessment. These measurements will be analyzed separately. This assessment is performed by parent/guardian.
次要结局
- Assessment of Differences in Parenting Stress Between Experimental and Control Group(At baseline and at 24 weeks)
- Self-assessment of Differences in Child's Quality of Life Between Experimental and Control Group(At baseline and at 24 weeks)
- Assessment of Differences in Child's Quality of Life Between Experimental and Control Group(At baseline and at 24 weeks)
研究者
Dan Handley, M.S., Ph.D.
Chief Scientific Officer
Clinical and Translational Genome Research Institute, Inc.