NCT02801604|Completed
Attentin® in Children and Adolescents With ADHD - A Non-interventional Study
Attention
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Attention
Sponsor study identifier
observational
150
1 country
1
Study Start
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2019
Actual (reported)Study Completion
December 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
June 2, 2016
Actual (reported)June 16, 2016
Actual (reported)November 2019
Actual (reported)December 2019
Actual (reported)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
baseline until 1st follow-up visit after 6 months
ADHD classification subgroup: Age
baseline until 1st follow-up visit after 6 months
ADHD classification subgroup: Dose under MPH therapy
baseline until 1st follow-up visit after 6 months
ADHD classification subgroup: Dose under dexamfetamine therapy
baseline until 1st follow-up visit after 6 months
ADHD classification subgroup: Baseline ADHD classification
baseline until 1st follow-up visit after 6 months
Dose-response relationship between dose under dexamfetamine and ADHD classification at 1st follow-up
at 1st follow-up visit, 6 months after baseline
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.
Child and Adolescent Psychiatry, University of Medicine
Mainz, Germany
Michael Huss, Prof. Dr.
Child and Adolescent Psychiatry, University of Medicine, Mainz, Germany
150 participants (actual enrollment reported by the registry).
First Submitted
June 2, 2016
First Posted
June 16, 2016
Study Start
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
November 2019
Actual (reported)Study Completion
December 2019
Actual (reported)Last Updated
September 2, 2020
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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