Attentin® in Children and Adolescents With ADHD - A Non-interventional Study

Study Overview
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Brief Summary
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The practicality of most ADHD medications is not or only moderately examined under long term routine conditions. Therefore, in this multi-centre, multi-national prospective non-interventional study, a recommended follow-up time of 12 months will investigate the course of the therapy in children and adolescents with ADHD with prior MPH treatment and their medication change to dexamfetamine in several European countries under daily routine. It consists of a baseline visit under MPH or another ADHD drug therapy, a change to dexamfetamine, the prospective description of the titration phase and a 12 month maintenance phase. Data on the use of dexamfetamine in routine clinical practice will be collected to describe how dexamfetamine is prescribed, titrated and used in the population of ADHD patients and how these factors influence the general intensity of ADHD and safety events. This study will collect real world data of dexamfetamine and compare descriptively the general intensity of ADHD according to ADHD classification and the impairment due to ADHD under therapy with dexamfetamine to the general intensity of ADHD according to ADHD classification and the impairment due to ADHD under the prior therapy with MPH. Furthermore the utilization of dexamfetamine will be assessed with regards to treatment persistence, compliance, proportion of patients discontinuing treatment and reason for discontinuation. Due to the fact that patients will be treated according to local medical practice it is possible that medication will be changed during the observation period.

Official Title
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Attentin® in Children and Adolescents With ADHD - A Non-interventional Study

Conditions
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Attention Deficit Hyperactivity Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 6 to 17.11 years Current MPH therapy insufficient ADHD was classified according to a validated classification system (e.g. DSM or ICD-10) No contraindication against dexamfetamine Exclusion Criteria: Contraindication against dexamfetamine

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 215 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD classification | change from baseline under MPH therapy to the 1st follow-up visit after 6 months under dexamfetamine, assessment by ADHD Rating Scale IV | baseline until 1st follow-up visit after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD classification subgroup: Age | change from baseline to 1st follow-up in subgroup of age in years | baseline until 1st follow-up visit after 6 months | 
| ADHD classification subgroup: Dose under MPH therapy | change from baseline to 1st follow-up in subgroup of MPH dose in mg | baseline until 1st follow-up visit after 6 months | 
| ADHD classification subgroup: Dose under dexamfetamine therapy | change from baseline to 1st follow-up in subgroup of dexamfetamine dose in mg | baseline until 1st follow-up visit after 6 months | 
| ADHD classification subgroup: Baseline ADHD classification | change from baseline to 1st follow-up in subgroup baseline ADHD classification, assessment by ADHD Rating Scale IV | baseline until 1st follow-up visit after 6 months | 
| Dose-response relationship between dose under dexamfetamine and ADHD classification at 1st follow-up |  | at 1st follow-up visit, 6 months after baseline | 
| ADHD classification change from baseline to titration and from baseline to 2nd follow-up after 1 year under dexamfetamine | Assessment by ADHD Rating Scale IV | baseline until 2nd follow-up visit after 1 year of examination | 
| Subscales hyperactivity/impulsivity | Assessment by ADHD Rating Scale IV | baseline until 2nd follow-up visit after 1 year of examination | 
| Subscales inattention | Assessment by ADHD Rating Scale IV | baseline until 2nd follow-up visit after 1 year of examination | 
| Response rate, relative reduction in ADHD classification from baseline to 1st follow-up of 30% or more |  | baseline until1st follow-up visit after 6 months | 
| Overall impairment of the patient's everyday life and disability due to ADHD concerning home life | Assessment for home life | baseline until 2nd follow-up visit after 1 year of examination | 
| Overall impairment of the patient's everyday life and disability due to ADHD concerning friendships | Assessment for friendships | baseline until 2nd follow-up visit after 1 year of examination | 
| Overall impairment of the patient's everyday life and disability due to ADHD concerning classroom learning | Assessment for classroom learning | baseline until 2nd follow-up visit after 1 year of examination | 
| Overall impairment of the patient's everyday life and disability due to ADHD concerning leisure activities | Assessment for leisure activities | baseline until 2nd follow-up visit after 1 year of examination | 
| Compliance of last MPH intake | estimated in per cent | baseline | 
| Compliance of last ADHD medication intake (other than MPH) | estimated in per cent | baseline | 
| Compliance of dexamfetamine intake | estimated in per cent | titration until 2nd follow-up visit after 1 year of examination | 
| Adverse Drug Reactions under ADHD medication, assessment of blood pressure in mmHg | Assessment of vital parameter: blood pressure in mmHg | baseline until 2nd follow-up visit after 1 year of examination | 
| Adverse Drug Reactions under ADHD medication, assessment of pulse in beats/min | Assessment of vital parameter: pulse in beats/min | baseline until 2nd follow-up visit after 1 year of examination | 
| Adverse Drug Reactions under ADHD medication, assessment of weight in kg | Assessment of vital parameter: weight in kg | baseline until 2nd follow-up visit after 1 year of examination | 
| Adverse Drug Reactions under ADHD medication, assessment of height in cm | Assessment of vital parameter: height in cm | baseline until 2nd follow-up visit after 1 year of examination |