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Attention Deficit Hyperactivity DisorderAttentionNCT02801604

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

An observational study of Attention Deficit Hyperactivity Disorder, run by Medice Arzneimittel Pütter GmbH & Co KG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 years to 215 months
Conditions the study is for
Attention Deficit Hyperactivity Disorder
How many people
150 participants
Where
1 siteGermany
Study dates
Jun 2016to Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years to 215 months
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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

Who cannot join

  • Contraindication against dexamfetamine

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Child and Adolescent Psychiatry, University of Medicine

    Mainz

Other trials in Germany

About this 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.

Medical subject headings
Attention Deficit Disorder with Hyperactivity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

Secondary outcomes (20)

  1. ADHD classification subgroup: Age

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

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

  2. ADHD classification subgroup: Dose under MPH therapy

    change from baseline to 1st follow-up in subgroup of MPH dose in mg

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

  3. ADHD classification subgroup: Dose under dexamfetamine therapy

    change from baseline to 1st follow-up in subgroup of dexamfetamine dose in mg

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

  4. ADHD classification subgroup: Baseline ADHD classification

    change from baseline to 1st follow-up in subgroup baseline ADHD classification, assessment by ADHD Rating Scale IV

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

  5. Dose-response relationship between dose under dexamfetamine and ADHD classification at 1st follow-up

    Measured: 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

    Assessment by ADHD Rating Scale IV

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

  7. Subscales hyperactivity/impulsivity

    Assessment by ADHD Rating Scale IV

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

  8. Subscales inattention

    Assessment by ADHD Rating Scale IV

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

  9. Response rate, relative reduction in ADHD classification from baseline to 1st follow-up of 30% or more

    Measured: 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

    Assessment for home life

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

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

    Assessment for friendships

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

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

    Assessment for classroom learning

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

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

    Assessment for leisure activities

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

  14. Compliance of last MPH intake

    estimated in per cent

    Measured: baseline

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

    estimated in per cent

    Measured: baseline

  16. Compliance of dexamfetamine intake

    estimated in per cent

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

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

    Assessment of vital parameter: blood pressure in mmHg

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

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

    Assessment of vital parameter: pulse in beats/min

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

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

    Assessment of vital parameter: weight in kg

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

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

    Assessment of vital parameter: height in cm

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionNov 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02801604
Sponsor's protocol ID
Attention
Acronym
Attention
Status last verified
Mar 2019
First submitted
2 Jun 2016
Last updated
2 Sep 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Attention Deficit Hyperactivity Disorder, run by Medice Arzneimittel Pütter GmbH & Co KG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ADHD classification (time frame: baseline until 1st follow-up visit after 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02801604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.

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