The Use of Lisdexamfetamine for Children Aged 7-13 With Attention Deficit Disorders

NCT04727476 | Unknown DMC

• 2 other identifiers: LDX-2013-2019IIR-DNK-002529
• Study Type: observational
• Target: 413
• Locations: 1 country
• Sites: 1

Brief Summary

Aiming at improving clinical practice regarding the use of lisdexamfetamine for the treatment of ADHD in children, the investigators want to retrospectively map the clinical use of lisdexamfetamine at a specialised outpatient clinic located at Aarhus University Hospital, Denmark treating children aged 7-13 with Attention Deficit Disorders in the period from 2013 to 2019. The investigators will describe the changes in prescription practice in the period, reported side effects and reasons for selecting and discontinuing treatment with lisdexamfetamine.

Conditions

Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder; Hyperkinetic Disorder

Keywords

ADHD; ADD; Lisdexamfetamine

Outcome Measures

Primary Outcomes (1)

• Lisdexamfetamine as first, second and third choice of treatment (+/- dexamfetamine as supplementary treatment).

  Number of patients receiving lisdexamfetamine as first, second and third choice (+/- dexamfetamine as supplementary treatment).

  Prescription of lisdexamfetamine sometime during the period from 1 April 2013 until 5 November 2019.

Secondary Outcomes (7)

• Duration of treatment.

  ADHD treatment prescribed in the period from 1 April 2013 to 5 November 2019.

• ADHD symptoms.

  At baseline and at the most stable dosage of a drug from prescription to discontinuation (first, second and third choice of treatment) in the period from 1 April to 5 November 2019..

• Adverse effects.

  All adverse effects registered during medical treatment from prescription to discontinuation of a drug (first, second and third choice of treatment) in the period from 1 April 2013 to 5 November 2019.to .

• Reasons for discontinuing medical treatment.

  At the time point (date) when a medical treatment is discontinued in the period from 1 April 2013 to 5 November 2019..

• Maximal dosage.

  The maximal dosage prescribed of a drug from first prescription to discontinuation (first, second and third choice of treatment) in the period from 1 April to 5 November 2019.

Study Arms (1)

Children with attention deficit disorders

children aged 7-13 years who have attended a specialised outpatient clinic treating children with attention deficit disorders i in the period from 1 April 2013 to 5 November 2019.

Drug: Lisdexamfetamine

Interventions

Lisdexamfetamine DRUG

Prescription of lisdexamfetamine sometime during til period from 1 April 2013 to 5 November 2019.

Children with attention deficit disorders

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The patients included in this study have attended a specialised outpatient clinic at the Department of Child and Adolescent Psychiatry at Aarhus University Hospital located in the Central Denmark Region. The specialised outpatient clinis treats children aged 7-13 years with moderate to severe ADHD. The catchment area of the Central Denmark Region comprises 1.3 million inhabitants. Patients are referred to the outpatient clinic from municipality services, general practitioners and to a lesser extent from other hospital units. The outpatient clinic is responsible for diagnosing and treating patients with the referral diagnosis of attention deficit disorder and comorbid conditions.

You may qualify if:

• Age 7-13 years at referral to the outpatient clinic.
• Have been diagnosed with one or more of the following ICD-10 diagnoses: F90.0 Disturbance of activity and attention; F90.1 Hyperkinetic conduct disorder; F90.8 Other hyperkinetic disorders; F90.9 Hyperkinetic disorder, unspecified; F98.8 Other specified behavioural and emotional disorders with onset usually occurring in childhood and adolescence (attention deficit disorder without hyperactivity, excessive masturbation, nail-biting, nose-picking, thumb-sucking), F98.8C Attention deficit disorder without hyperactivity.
• Manual review of patients with the diagnosis F98.8 is deemed necessary to identify all patients with attention deficit disorder without hyperactivity due to changed diagnostic practice.
• Prescription of lisdexamfetamine sometime during the period from 1 April 2013 to 5 November 2019.

You may not qualify if:

• Prescribtion of ADHD medication prior to 1 April 2013.
• Patients with the diagnosis F98.8 with the following denominations will be excluded; excessive masturbation, nail-biting, nose-picking, thumb-sucking.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Takeda: collaborator

Study Sites (1)

Department of Child and Adolescent Psychiatry, Aarhus University Hospital

Aarhus, Region Midt, 8200, Denmark

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Nanna Roed Soendergaard, MD

  Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 27, 2021
• Study Start: January 19, 2021
• Primary Completion: August 10, 2021
• Study Completion: May 1, 2022
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)