Child and Adolescent Psychiatry, University of Medicine
Mainz, Germany
NCT Number: NCT02801604
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.
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Notify Me6 year–215 month
All sexes
Observational
Mainz, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: baseline until 1st follow-up visit after 6 months
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
change from baseline to 1st follow-up in subgroup of age in years
Time frame: baseline until 1st follow-up visit after 6 months
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
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
change from baseline to 1st follow-up in subgroup baseline ADHD classification, assessment by ADHD Rating Scale IV
Time frame: at 1st follow-up visit, 6 months after baseline
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Assessment by ADHD Rating Scale IV
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Assessment by ADHD Rating Scale IV
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Assessment by ADHD Rating Scale IV
Time frame: baseline until1st follow-up visit after 6 months
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Assessment for home life
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Assessment for friendships
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Assessment for classroom learning
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Assessment for leisure activities
Time frame: baseline
estimated in per cent
Time frame: baseline
estimated in per cent
Time frame: titration until 2nd follow-up visit after 1 year of examination
estimated in per cent
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Assessment of vital parameter: blood pressure in mmHg
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Assessment of vital parameter: pulse in beats/min
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Assessment of vital parameter: weight in kg
Time frame: baseline until 2nd follow-up visit after 1 year of examination
Assessment of vital parameter: height in cm
Medice Arzneimittel Pütter GmbH & Co KG
Industry
Acronym: Attention
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