The Difference in Pharmacodynamic and Pharmacokinetic Profiles Between Tentin and Magisterial Dexamfetamine in Adults With Attention Deficit Hyperactivity Disorder, a Double Blinded Randomised Crossover-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Quantified behavior Test (QbTest) - Time Active
研究概览
简要总结
The goal of this clinical trial is to compare in the pk/pd profiles of magisterial dexamfetamine and Tentin in adults with Attention Deficit Hyperactivity Disorder (ADHD). The main question[s] it aims to answer are:
Q1: is there a difference between pk/pd profiles of the two forms of dexamfetamine?
Q2: how does the pharmacokinetic variability influences the objective and subjective (side) effects experienced by adult patients with ADHD?
Participants will:
- take the Quantified behavior Test for analysis of objective effects.
- undergo blood sampling for analysis of the plasma concentration of dexamphetamine.
- undergo blood pressure and heart rate measurements.
- fill out 4 types of questionnaires.
Researchers will compare the outcomes between magisterial dexamphetamine and Tentin use in a crossover setting.
详细描述
Objectives The primary objective is to compare the pharmacological profile of the magisterial form of dexamfetamine sulfate to the pharmacological profile of the brand-name form of dexamfetamine (Tentin©) in adult patients diagnosed with attention deficit hyperactivity disorder (ADHD) and assess whether there is a difference between pk/pd profiles of the two forms of dexamfetamine. The secondary objective is to assess how pharmacokinetic variability influences the objective and subjective (side) effects experienced by adult patients with ADHD.
Measurements At three moments (0, 60 and 120 minutes after drug administration) on each intervention-day, participants will complete the QbTest to assess objective performance and the QbPerformance to assess subjective performance. At eight moments (0, 45, 60, 75, 90, 120, 150 and 180 minutes after drug administration) on each intervention-day, participants will undergo blood sampling to determine dexamfetamine plasma concentrations and vital sign measurements for safety monitoring and possible outcome-effects. At eight moments (0, 45, 60, 75, 90, 120, 150 and 180 minutes after drug administration) on each intervention-day, participants will fill out questionnaires to assess subjective experiences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is aged ≥ 18 years at time of screening.
- •Participant is diagnosed with ADHD according to the DSM 5 criteria.
- •Participant has switched from Tentin© to magisterial dexamfetamine due to the adverse effects of Tentin.
- •Participant is being treated adequately with dexamphetamine, as determined by their practitioner, at time of screening.
- •Participant or their legal representative is able and willing to provide written informed consent.
- •Participant is able and willing to comply with the study protocol (e.g. swallow capsules, have blood samples taken, can visit the outpatient clinic twice).
- •Participant has not participated in another study in the past three months.
排除标准
- •Participant has a disorder that might affect drug absorption (e.g. gastrointestinal, metabolic, endocrine or liver disorder).
- •Participant is allergic to the ingredients of the capsules.
研究组 & 干预措施
Magisterial Dexamphetamine
Magisterial Dexamphetamine
干预措施: Dexamfetamine (Drug)
Tentin
Tentin
干预措施: Dexamfetamine (Drug)
结局指标
主要结局
Quantified behavior Test (QbTest) - Time Active
时间窗: 0-120 minutes after drug administration
Time Active for analysis of objective effects. The Quantified behaviour Test (QbTest) provides data to assess the three core symptoms of ADHD, that is: hyperactivity, inattention and impulsivity. Time Active (in %) is one of the scores used to measure hyperactivity, inattention and impulsivity. For the current study cardinal outcomes will be derived from a Principal Component Analysis.
Quantified behavior Test (QbTest) - Distance
时间窗: 0-120 minutes after drug administration
Distance for analysis of objective effects. The Quantified behaviour Test (QbTest) provides data to assess the three core symptoms of ADHD, that is: hyperactivity, inattention and impulsivity. Distance (in meters) is one of the scores used to measure hyperactivity, inattention and impulsivity. For the current study cardinal outcomes will be derived from a Principal Component Analysis.
Quantified behavior Test (QbTest) - Micro Events
时间窗: 0-120 minutes after drug administration
Micro Events for analysis of objective effects. The Quantified behaviour Test (QbTest) provides data to assess the three core symptoms of ADHD, that is: hyperactivity, inattention and impulsivity. Micro Events (in millimeters) is one of the scores used to measure hyperactivity, inattention and impulsivity. For the current study cardinal outcomes will be derived from a Principal Component Analysis.
Quantified behavior Test (QbTest) - Area
时间窗: 0-120 minutes after drug administration
Area for analysis of objective effects. The Quantified behaviour Test (QbTest) provides data to assess the three core symptoms of ADHD, that is: hyperactivity, inattention and impulsivity. Area (in cm2) is one of the scores used to measure hyperactivity, inattention and impulsivity. For the current study cardinal outcomes will be derived from a Principal Component Analysis.
Quantified behavior Test (QbTest) - Motion Simplicity
时间窗: 0-120 minutes after drug administration
Motion Simplicity for analysis of objective effects. The Quantified behaviour Test (QbTest) provides data to assess the three core symptoms of ADHD, that is: hyperactivity, inattention and impulsivity. Motion Simplicity (in %) is one of the scores used to measure hyperactivity, inattention and impulsivity. For the current study cardinal outcomes will be derived from a Principal Component Analysis.
Blood samples
时间窗: 0-180 minutes after drug administration
For analysis of the plasma concentration of dexamfetamine.
Blood pressure
时间窗: 0-180 minutes after drug administration
For autonomic and adverse effects measurements. Measured in mmHg Normal value: 120/80 mmHg
Heart rate
时间窗: 0-180 minutes after drug administration
For autonomic and adverse effects measurements. Measured in BPM Normal value: 60-100 BPM
次要结局
- Bond-Lader Visual Analog Scale (BL-VAS)(0-180 minutes after drug administration)
- QbTest performance questionnaire(0-180 minutes after drug administration)
- Addiction Research Centre Inventory (ARCI) - Acute Subjective Response to Substances (ASRS): Amphetamine Scale(45-180 minutes after drug administration)
研究者
Glenn Dumont
Associate professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)