Pharmacogenomics of Stimulant Treatment Response in Children and Adolescents With Attention-Deficit/ Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Side effect frequency and severity
研究概览
简要总结
The "Pharmacogenomics of Stimulant Treatment Response" (PGx-STaR) study aims to identify genetic profiles related to methylphenidate treatment outcomes in children and adolescents aged 6-24 with Attention deficit/hyperactivity disorder (ADHD).
详细描述
Background: ADHD is a common neurodevelopmental disorder affecting children and adolescents, with psychostimulants, specifically slow-release methylphenidate (e.g., Biphentin®, Concerta®), being a first-line treatment option. However, the response to medications varies significantly among individuals, with some experiencing limited benefits or intolerable side effects. Unlike other areas of psychiatry, ADHD pharmacotherapy lacks genetic markers to guide treatment decisions, resulting in delayed symptom relief and diminished quality of life for patients.
Objectives:
- Identifying genomic profiles associated with psychostimulant treatment response and tolerability in children and adolescents with ADHD.
- Establishing a research platform for the discovery of new genetic and non-genetic markers of drug treatment outcomes relevant to mental health care in children.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible for participation if all the following are true.
- •Aged 6 - 24 years.
- •Located in Western Canada (i.e., Alberta, British Columbia, Saskatchewan, Manitoba).
- •Primary diagnosis of ADHD (all types).
- •Starting Methylphenidate (excluding immediate release forms) treatment.
排除标准
- •Patients will be excluded from participation if any of the following are true.
- •Co-occurring psychotic, bipolar or eating disorders.
- •Significant risk of suicide.
- •An intellectual disability, or diagnosis of autism spectrum disorder (ASD) or tics/Tourette disorders.
- •Past 12-month high-risk alcohol or substance use defined as monthly or more frequent use.
- •Psychotherapy or brain stimulation-based therapy initiated within 8 weeks of referral or plans to initiate/change these types of therapies during the study
- •History of liver or bone marrow (hematopoietic cell) transplant as these events can result in ambiguous genomic results.
结局指标
主要结局
Side effect frequency and severity
时间窗: 1, 2, 3, and 4 weeks post-baseline
CADDRA ADHD Medication and Side Effect Form
Change in ADHD symptom severity
时间窗: Baseline and 1, 2, 3, and 4 weeks post-baseline
Strengths and Weaknesses of Attention-Deficit/Hyperactivity Symptoms and Normal Behavior Scale (SWAN) Rating Scale for ADHD. Score range = -90 to +90, with higher scores indicative of worse outcome.
次要结局
- Methylphenidate/ritalinic acid exposure(4 weeks post-baseline)
- Change in impulse control(Baseline and 4 weeks post-baseline)
- Change in functioning(Baseline and 4 weeks post-baseline)
- Change in working memory(Baseline and 4 weeks post-baseline)
- Change in attention(Baseline and 4 weeks post-baseline)
- Change in inhibitory control(Baseline and 4 weeks post-baseline)
- Change in child quality of life(Baseline and 4 weeks post-baseline)
- Change in carer quality of life(Baseline and 4 weeks post-baseline)
研究者
Chad Bousman
Associate Professor
University of Calgary