Clinical trial NCT02801604: Attentin® in Children and Adolescents With ADHD - A Non-interventional Study
Official title: Attentin® in Children and Adolescents With ADHD - A Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Medice Arzneimittel Pütter GmbH & Co KG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Essen
First posted: 2016-06-16
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 215
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents (Age ≥ 6 to 17.11 years) with ADHD, who were treated with methylphenidate (MPH) in the past and, when response to previous MPH treatment is considered clinically inadequate, will be treated with dexamfetamine in this non-interventional study. ADHD was classified according to a classification system of the DSM or ICD and the patient should have no contraindication against dexamfetamine.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: ADHD classification
timeFrame: baseline until 1st follow-up visit after 6 months
Secondary outcomes:
measure: ADHD classification subgroup: Age
timeFrame: baseline until 1st follow-up visit after 6 months
measure: ADHD classification subgroup: Dose under MPH therapy
timeFrame: baseline until 1st follow-up visit after 6 months
measure: ADHD classification subgroup: Dose under dexamfetamine therapy
timeFrame: baseline until 1st follow-up visit after 6 months
measure: ADHD classification subgroup: Baseline ADHD classification
timeFrame: baseline until 1st follow-up visit after 6 months
measure: Dose-response relationship between dose under dexamfetamine and ADHD classification at 1st follow-up
timeFrame: at 1st follow-up visit, 6 months after baseline
measure: ADHD classification change from baseline to titration and from baseline to 2nd follow-up after 1 year under dexamfetamine
timeFrame: baseline until 2nd follow-up visit after 1 year of examination
measure: Subscales hyperactivity/impulsivity
timeFrame: baseline until 2nd follow-up visit after 1 year of examination
measure: Subscales inattention
timeFrame: baseline until 2nd follow-up visit after 1 year of examination
measure: Response rate, relative reduction in ADHD classification from baseline to 1st follow-up of 30% or more
timeFrame: baseline until1st follow-up visit after 6 months
measure: Overall impairment of the patient's everyday life and disability due to ADHD concerning home life
timeFrame: baseline until 2nd follow-up visit after 1 year of examination
measure: Overall impairment of the patient's everyday life and disability due to ADHD concerning friendships
timeFrame: baseline until 2nd follow-up visit after 1 year of examination
measure: Overall impairment of the patient's everyday life and disability due to ADHD concerning classroom learning
timeFrame: baseline until 2nd follow-up visit after 1 year of examination
measure: Overall impairment of the patient's everyday life and disability due to ADHD concerning leisure activities
timeFrame: baseline until 2nd follow-up visit after 1 year of examination
measure: Compliance of last MPH intake
timeFrame: baseline
measure: Compliance of last ADHD medication intake (other than MPH)
timeFrame: baseline
measure: Compliance of dexamfetamine intake
timeFrame: titration until 2nd follow-up visit after 1 year of examination
measure: Adverse Drug Reactions under ADHD medication, assessment of blood pressure in mmHg
timeFrame: baseline until 2nd follow-up visit after 1 year of examination
measure: Adverse Drug Reactions under ADHD medication, assessment of pulse in beats/min
timeFrame: baseline until 2nd follow-up visit after 1 year of examination
measure: Adverse Drug Reactions under ADHD medication, assessment of weight in kg
timeFrame: baseline until 2nd follow-up visit after 1 year of examination
measure: Adverse Drug Reactions under ADHD medication, assessment of height in cm
timeFrame: baseline until 2nd follow-up visit after 1 year of examination
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Child and Adolescent Psychiatry, University of Medicine
Study officials:
affiliation: Child and Adolescent Psychiatry, University of Medicine, Mainz, Germany
name: Michael Huss, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: