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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany
    • Child and Adolescent Psychiatry, University of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD classification subgroup: Age	change from baseline to 1st follow-up in subgroup of age in years	baseline until 1st follow-up visit after 6 months
ADHD classification subgroup: Dose under MPH therapy	change from baseline to 1st follow-up in subgroup of MPH dose in mg	baseline until 1st follow-up visit after 6 months
ADHD classification subgroup: Dose under dexamfetamine therapy	change from baseline to 1st follow-up in subgroup of dexamfetamine dose in mg	baseline until 1st follow-up visit after 6 months
ADHD classification subgroup: Baseline ADHD classification	change from baseline to 1st follow-up in subgroup baseline ADHD classification, assessment by ADHD Rating Scale IV	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
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	baseline until 2nd follow-up visit after 1 year of examination
Subscales hyperactivity/impulsivity	Assessment by ADHD Rating Scale IV	baseline until 2nd follow-up visit after 1 year of examination
Subscales inattention	Assessment by ADHD Rating Scale IV	baseline until 2nd follow-up visit after 1 year of examination
Response rate, relative reduction in ADHD classification from baseline to 1st follow-up of 30% or more		baseline until1st follow-up visit after 6 months
Overall impairment of the patient's everyday life and disability due to ADHD concerning home life	Assessment for home life	baseline until 2nd follow-up visit after 1 year of examination
Overall impairment of the patient's everyday life and disability due to ADHD concerning friendships	Assessment for friendships	baseline until 2nd follow-up visit after 1 year of examination
Overall impairment of the patient's everyday life and disability due to ADHD concerning classroom learning	Assessment for classroom learning	baseline until 2nd follow-up visit after 1 year of examination
Overall impairment of the patient's everyday life and disability due to ADHD concerning leisure activities	Assessment for leisure activities	baseline until 2nd follow-up visit after 1 year of examination
Compliance of last MPH intake	estimated in per cent	baseline
Compliance of last ADHD medication intake (other than MPH)	estimated in per cent	baseline
Compliance of dexamfetamine intake	estimated in per cent	titration until 2nd follow-up visit after 1 year of examination
Adverse Drug Reactions under ADHD medication, assessment of blood pressure in mmHg	Assessment of vital parameter: blood pressure in mmHg	baseline until 2nd follow-up visit after 1 year of examination
Adverse Drug Reactions under ADHD medication, assessment of pulse in beats/min	Assessment of vital parameter: pulse in beats/min	baseline until 2nd follow-up visit after 1 year of examination
Adverse Drug Reactions under ADHD medication, assessment of weight in kg	Assessment of vital parameter: weight in kg	baseline until 2nd follow-up visit after 1 year of examination
Adverse Drug Reactions under ADHD medication, assessment of height in cm	Assessment of vital parameter: height in cm	baseline until 2nd follow-up visit after 1 year of examination

Collaborators and Investigators

• Sponsor: Medice Arzneimittel Pütter GmbH & Co KG
• Collaborators: University Hospital, Essen
• Investigators: Principal Investigator: Michael Huss, Prof. Dr., Child and Adolescent Psychiatry, University of Medicine, Mainz, Germany

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: Attention

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No