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

NCT02801604 | Completed

• 1 other identifier: Attention
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (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

  baseline until 1st follow-up visit after 6 months

Secondary Outcomes (20)

• 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

Eligibility Criteria

• Age: 6 Years - 215 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Contraindication against dexamfetamine

Sponsors & Collaborators

• Medice Arzneimittel Pütter GmbH & Co KG: lead
• University Hospital, Essen: collaborator

Study Sites (1)

Child and Adolescent Psychiatry, University of Medicine

Mainz, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Michael Huss, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 16, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 2, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)