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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801604
Recruitment Status : Active, not recruiting
First Posted : June 16, 2016
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
University Hospital, Essen
Information provided by (Responsible Party):
Medice Arzneimittel Pütter GmbH & Co KG

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.


Condition or disease
Attention Deficit Hyperactivity Disorder

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Attentin® in Children and Adolescents With ADHD - A Non-interventional Study
Study Start Date : June 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 215 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801604


Locations
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Germany
Child and Adolescent Psychiatry, University of Medicine
Mainz, Germany
Sponsors and Collaborators
Medice Arzneimittel Pütter GmbH & Co KG
University Hospital, Essen
Investigators
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Principal Investigator: Michael Huss, Prof. Dr. Child and Adolescent Psychiatry, University of Medicine, Mainz, Germany
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Responsible Party: Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier: NCT02801604    
Other Study ID Numbers: Attention
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders