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Completed

NCT Number: NCT02801604

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

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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Key information

Age range

6 year–215 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Child and Adolescent Psychiatry, University of Medicine

Mainz, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. ADHD classification

    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

Secondary outcomes

  1. ADHD classification subgroup: Age

    Time frame: baseline until 1st follow-up visit after 6 months

    change from baseline to 1st follow-up in subgroup of age in years

  2. ADHD classification subgroup: Dose under MPH therapy

    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

  3. ADHD classification subgroup: Dose under dexamfetamine therapy

    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

  4. ADHD classification subgroup: Baseline ADHD classification

    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

  5. 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

  6. ADHD classification change from baseline to titration and from baseline to 2nd follow-up after 1 year under dexamfetamine

    Time frame: baseline until 2nd follow-up visit after 1 year of examination

    Assessment by ADHD Rating Scale IV

  7. Subscales hyperactivity/impulsivity

    Time frame: baseline until 2nd follow-up visit after 1 year of examination

    Assessment by ADHD Rating Scale IV

  8. Subscales inattention

    Time frame: baseline until 2nd follow-up visit after 1 year of examination

    Assessment by ADHD Rating Scale IV

  9. 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

  10. Overall impairment of the patient's everyday life and disability due to ADHD concerning home life

    Time frame: baseline until 2nd follow-up visit after 1 year of examination

    Assessment for home life

  11. Overall impairment of the patient's everyday life and disability due to ADHD concerning friendships

    Time frame: baseline until 2nd follow-up visit after 1 year of examination

    Assessment for friendships

  12. Overall impairment of the patient's everyday life and disability due to ADHD concerning classroom learning

    Time frame: baseline until 2nd follow-up visit after 1 year of examination

    Assessment for classroom learning

  13. Overall impairment of the patient's everyday life and disability due to ADHD concerning leisure activities

    Time frame: baseline until 2nd follow-up visit after 1 year of examination

    Assessment for leisure activities

  14. Compliance of last MPH intake

    Time frame: baseline

    estimated in per cent

  15. Compliance of last ADHD medication intake (other than MPH)

    Time frame: baseline

    estimated in per cent

  16. Compliance of dexamfetamine intake

    Time frame: titration until 2nd follow-up visit after 1 year of examination

    estimated in per cent

  17. Adverse Drug Reactions under ADHD medication, assessment of blood pressure in mmHg

    Time frame: baseline until 2nd follow-up visit after 1 year of examination

    Assessment of vital parameter: blood pressure in mmHg

  18. Adverse Drug Reactions under ADHD medication, assessment of pulse in beats/min

    Time frame: baseline until 2nd follow-up visit after 1 year of examination

    Assessment of vital parameter: pulse in beats/min

  19. Adverse Drug Reactions under ADHD medication, assessment of weight in kg

    Time frame: baseline until 2nd follow-up visit after 1 year of examination

    Assessment of vital parameter: weight in kg

  20. Adverse Drug Reactions under ADHD medication, assessment of height in cm

    Time frame: baseline until 2nd follow-up visit after 1 year of examination

    Assessment of vital parameter: height in cm

Sponsors and collaborators

Lead sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Industry

Collaborators

  • University Hospital, Essen

Registry information

Acronym: Attention

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 16, 2016
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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