International Study to Predict Optimised Treatment in Children and Adolescents with Attention Deficit/Hyperactivity Disorder

International Study to Predict Optimised Treatment response to short-acting methylphenidate in children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD) as compared to matched healthy controls.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000271202

Acronym

iSPOT-A

Enrollment

1344

Registered

2009-05-15

Start date

2009-04-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purposes of the iSPOT-A study are 1) to identify objective markers of ADHD, using cognitive, brain and genetic markers, and 2) to identify objective markers that predict treatment response to short-acting methylphenidate using cognitive, brain and genetic markers.

Interventions

Once Baseline testing is completed, ADHD subjects will be dosed with short-acting methylphenidate as per local/country standard of care. Therefore, the length of treatment will differ and is based on the subjects response. Baseline testing consists of a clinical interview and medical history, a pregnancy test (for females of childbearing potential), web-based questionnaire, psychophysiology data collection, touchscreen cognitive testing, saliva collection for Deoxyribonucleic acid (DNA) analysis. A urine sample may be requested to rule out current illicit drug use. Structural and Functional Magnetic Resonance Imaging (MRI) will be performed at selected sites and in 10% of subjects. This part of the baseline assessment is optional. Baseline testing is expected to take up to 7 hours and may be completed over 2 days. Recommended Dosage: 5 mg twice daily given as oral tablets with gradual increments of 5 to 10 mg weekly. Daily dosage above 60 mg is not recommended.

Study design

Allocation

Non-randomised trial

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

6 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

Meet Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for primary diagnosis of ADHD, have an Attention Deficit / Hyperactivity Disorder Rating Scale (ADHD-RS IV) score > 6 for inattention and/or hyperactivity-impulsivity, subject is a candidate for methylphenidate, and is stimulant naive or stimulant free. Fluent and literate in English or Dutch.

Exclusion criteria

Prior or recent use of methylphenidate of other stimulant medication. History of brain injury/blow resulting in loss of consciousness. Severe impediment to vision, hearing and/or hand movement which may interfere with their ability to complete the protocol required tests.

Outcome results