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.
Study Type
OBSERVATIONAL
Enrollment
150
Child and Adolescent Psychiatry, University of Medicine
Mainz, Germany
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
Time frame: baseline until 1st follow-up visit after 6 months
ADHD classification subgroup: Age
change from baseline to 1st follow-up in subgroup of age in years
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline until 1st follow-up visit after 6 months
Dose-response relationship between dose under dexamfetamine and ADHD classification at 1st follow-up
Time frame: 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
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Subscales hyperactivity/impulsivity
Assessment by ADHD Rating Scale IV
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Subscales inattention
Assessment by ADHD Rating Scale IV
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Compliance of last MPH intake
estimated in per cent
Time frame: baseline
Compliance of last ADHD medication intake (other than MPH)
estimated in per cent
Time frame: baseline
Compliance of dexamfetamine intake
estimated in per cent
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline until 2nd follow-up visit after 1 year of examination
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