NCT02136147

Brief Summary

ADHD medication of children and adolescents is becoming increasingly common. Clinical experience and scientific studies have proven that approximately 30% of children/adolescents with ADHD do not benefit from this treatment. However, there is insufficient knowledge about who these children are. All children and adolescents, who start treatment with ADHD medication at public Child and Adolescent Psychiatry units in Stockholm, on Gotland, an in Västerbotten, will be asked to participate in the study. The investigators intend to monitor the patients´clinical symptoms and possible side-effects after treatment start. The investigators will collect background information and saliva samples from the patient and his/her parents to be able to study if there are any genetic (hereditary) or other markers that can predict positive or negative outcomes of the ADHD medication. With this information, the investigators aim at, to a greater extent, be able to individualize treatment choices for children and adolescents with ADHD without unnecessary, costly and possibly unfavorable treatment attempts.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
632

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

6.1 years

First QC Date

April 30, 2014

Last Update Submit

October 16, 2023

Conditions

Keywords

Attention Deficit Disorder with HyperactivityNeuropsychiatryDrug therapyPharmacogeneticsChild Psychiatry

Outcome Measures

Primary Outcomes (2)

  • change in SNAP-IV Teacher and Parent rating scale (Swanson, Nolan and Pelham ADHD Rating Scale)

    ADHD symptoms

    at 3 months follow-up

  • change in P-SEC (Pediatric Side Effects Checklist)

    Side-effect measure

    at 3 months follow-up

Secondary Outcomes (34)

  • change in C-GAS (Children´s global assessment scale)

    at 12 months follow-up

  • change in CGI-S (Clinical Global Impression- of Severity)

    at 12 months follow-up

  • change in SNAP-IV Teacher and Parent rating scale

    at 1 month follow-up

  • change in SNAP-IV Teacher and Parent rating scale

    at 6 months follow-up

  • change in SNAP-IV Teacher and Parent rating scale

    at 12 months follow-up

  • +29 more secondary outcomes

Other Outcomes (2)

  • change in self-harm frequency

    at 12 months follow-up

  • change in suicide attempt frequency

    at 12 months follow-up

Study Arms (5)

Children with ADHD medication

Identified responders and non-responders in children/adolescents starting medication for treatment of ADHD in public child and adolescent psychiatric services in Stockholm, on Gotland, and in Västerbotten.

Drug: methylphenidate medicationDrug: atomoxetine medicationDrug: lisdexamphetamine medicationDrug: guanfacine medication

Lisdexamphetamine medication

Identified responders and non-responders in children/adolescents starting medication with lisdexamphetamine in public child and adolescent psychiatric services in Stockholm and on Gotland.

Drug: lisdexamphetamine medication

Atomoxetine medication

Identified responders and non-responders in children/adolescents starting medication with atomoxetine in public child and adolescent psychiatric services in Stockholm and on Gotland.

Drug: atomoxetine medication

Methylphenidate medication

Identified responders and non-responders in children/adolescents starting medication with methylphenidate in public child and adolescent psychiatric services in Stockholm and on Gotland.

Drug: methylphenidate medication

Guanfacine medication

Identified responders and non-responders in children/adolescents starting medication with guanfacine in public child and adolescent psychiatric services in Stockholm and on Gotland.

Drug: guanfacine medication

Interventions

Also known as: N06BA04, Concerta, Ritalin, Equasym, Medikinet
Children with ADHD medicationMethylphenidate medication
Also known as: N06BA09, Strattera
Atomoxetine medicationChildren with ADHD medication
Also known as: N06BA12, Elvanse
Children with ADHD medicationLisdexamphetamine medication
Also known as: C02AC02, Intuniv
Children with ADHD medicationGuanfacine medication

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All children/adolescents starting ADHD medication at the public child and adolescent psychiatry services in Stockholm and on Gotland

You may qualify if:

  • Clinical diagnosis of ADHD
  • Starting medication against ADHD symptoms with atomoxetine, methylphenidate, lisdexamphetamine, or guanfacine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division for Child and Adolescent Psychiatry in Stockholm

Stockholm, Stockholm County, Sweden

Location

Related Publications (2)

  • Lilja MM, Lichtenstein P, Serlachius E, Bhagia J, Malmberg K, Malm C, Lenhard F, Halldner L. Can response to ADHD medication be predicted? Eur Child Adolesc Psychiatry. 2025 Aug;34(8):2431-2442. doi: 10.1007/s00787-025-02650-8. Epub 2025 Jan 29.

  • Lilja MM, Sandblom E, Lichtenstein P, Serlachius E, Hellner C, Bhagia J, Halldner L. The effect of autistic traits on response to and side-effects of pharmacological ADHD treatment in children with ADHD: results from a prospective clinical cohort. J Neurodev Disord. 2022 Mar 6;14(1):17. doi: 10.1186/s11689-022-09424-2.

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

MethylphenidateAtomoxetine HydrochlorideLisdexamfetamine DimesylateGuanfacine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesDextroamphetamineAmphetamineAmphetaminesPhenethylaminesEthylaminesGuanidinesAmidines

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 12, 2014

Study Start

June 1, 2015

Primary Completion

July 1, 2021

Study Completion

June 1, 2022

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations