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Attention Deficit Disorder With Hyperactivity (ADHD) | ADHD Medication and Predictors of Treatment Outcome

Attention Deficit Disorder With Hyperactivity (ADHD) research study

What is the primary objective of this study?

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 and on Gotland, 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.

Who is eligible to participate?

Inclusion Criteria: - Clinical diagnosis of ADHD - Starting medication against ADHD symptoms with atomoxetine, methylphenidate or lisdexamphetamine Exclusion Criteria: Any medication against ADHD the last 3 months

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Attention Deficit Disorder With Hyperactivity (ADHD)

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:methylphenidate medication

Drug:atomoxetine medication

Drug:lisdexamphetamine medication

Drug:guanfacine medication

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Children with ADHD medicationIdentified responders and non-responders in children/adolescents starting medication for treatment of ADHD in public child and adolescent psychiatric services in Stockholm and on Gotland.

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

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

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

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

Study Status

Enrolling by invitation

Start Date: June 2015

Completed Date:

Phase: N/A

Type: Observational [Patient Registry]

Design:

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

Secondary Outcome: change in C-GAS (Children´s global assessment scale)

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Karolinska Institutet

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02136147

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