International Study to Predict Optimised Treatment in Attention Deficit/Hyperactivity Disorder

NCT00863499 | Unknown Phase 4

• 1 other identifier: iSPOT-A
• Study Type: interventional
• Target: 1,344
• Locations: 3 countries
• Sites: 7

Brief Summary

The aim of the iSPOT-A study is to:

1. 1.identify brain, genetic and cognitive markers of Attention Deficit/Hyperactivity Disorder, and
2. 2.identify brain, genetic and cognitive markers that predict treatment response to short-acting methylphenidate in children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder.

Conditions

Attention Deficit/Hyperactivity Disorder

Keywords

Attention Deficit/Hyperactivity Disorder; Attention Deficit Disorder; ADHD; ADD; iSPOT

Outcome Measures

Primary Outcomes (1)

• To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD.

  6 weeks

Secondary Outcomes (1)

• To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.

  52 weeks

Study Arms (3)

A

ACTIVE COMPARATOR

Short Acting methylphenidate

Drug: Short Acting Methylphenidate

B

ACTIVE COMPARATOR

Long Acting Methylphenidate

Drug: Long Acting Methylphenidate

C

NO INTERVENTION

Healthy Controls

Interventions

Short Acting Methylphenidate DRUG

Dosage: 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly. Daily dosage above 60 mg is not recommended.

Also known as: • Ritalin, • Ritalina, • Attenta, • Methylin, • Penid, • Rubifen, *Consider treatment directions above or as physician directed as per usual care.

A

Long Acting Methylphenidate DRUG

Dosage: 9 to 20 mg once daily in the morning (with or without food) with gradual increments of 9 to 20 mg weekly. Daily dosage above 60 mg is not recommended.

Also known as: • Concerta, • Metadate CD, • Methylin ER, • Ritalin LA, • Ritalin Sustained-Release, *Consider treatment directions above or as physician directed as per usual care.

B

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who have signed an informed consent or assent form where required and/or whose parent or legal guardian has provided written informed consent.
• Subjects who meet DSM-IV criteria for primary diagnosis of ADHD at study entry, as determined by a psychiatrist, physician or clinical psychologist in conjunction with the clinical work-up undertaken by trained research assistants, as defined by The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI Kid).
• Subjects who score at least 6 Inattentive or Hyperactive/impulsive items \>1 on the Attention Deficit / Hyperactivity Disorder Rating Scale.
• Subjects who are stimulant naïve or stimulant free (defined as no stimulant medication in the previous 7 days\*).
• Subjects who are 6-17 years of age (with an emphasis to enrol at least a third of the subjects who are ≥ 13 years of age).
• Subjects who are fluent and literate in English (and/or Dutch in The Netherlands).
• coming off the stimulant medication for 7 days may place the participant at increased risk, therefore, the participant may have this washout period reduced to that defined in the drug package insert or 5 times the medication half life.

You may not qualify if:

• Known contra-indication or intolerance to the use of methylphenidate as defined in the product package insert (including previous treatment failure at the highest recommended dose).
• Pregnancy and females of child bearing potential who are not using a form of contraception and are at risk of becoming pregnant during the study.
• Known medical condition, disease or neurological disorder which might, in the opinion of investigator/s, interfere with the assessments to be made in the study or put ADHD patients at increased risk when exposed to optimal doses of the drug treatment. For example, a diagnosis of epilepsy would exclude a patient from this trial.
• History of physical brain injury or blow to the head that resulted in loss of consciousness for at least 10 minutes or at least 5minutes within the last two years. Prior treatment with methylphenidate or any other stimulant medication in the past 7 days.
• Known past or present substance dependence, including alcohol, as determined by The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI Kid).
• Participation in an investigational study within four months of the baseline visit in which subjects have received an experimental drug/device that could affect the primary end points of this study.
• Use of any psychological or counselling therapy or CNS medication that cannot be washed out prior to participation or use of any psychological or counselling therapy between the baseline and week 6 (or Early Termination) visits.
• Subjects who, in the opinion of the investigator, have a severe impediment to vision, hearing and/or hand movement, which is likely to interfere with their ability to complete the testing batteries.
• Subjects who, in the opinion of the investigator, are unable and/or unlikely to comprehend and follow the study procedures and instructions.
• Presence of any other co-morbid primary DSM IV disorder.

Sponsors & Collaborators

• BRC Operations Pty. Ltd.: lead

Study Sites (7)

Shanti Clinical Trials

Colton, California, 92324, United States

Location

Center for Healing the Human Spirit

Tarzana, California, 91356, United States

Location

Brain Resource Center

Englewood Cliffs, New Jersey, 07632, United States

Location

Brain Resource Center

New York, New York, 10023, United States

Location

Skyland Behavioral Health Associates , P.A.

Asheville, North Carolina, 28801, United States

Location

Brain Dynamics Centre

Westmead, New South Wales, 2145, Australia

Location

Brainclinics Diagnostics B.V.

Nijmegen, Gelderland, 6524 AD, Netherlands

Location

Related Publications (2)

• Leikauf JE, Griffiths KR, Clarke SD, Kohn MR, Williams L. Attention-Deficit/Hyperactivity Disorder Subtypes Defined by Cognition Have a Distinct Neural and Clinical Profile and Differ in Response to Atomoxetine. J Am Acad Child Adolesc Psychiatry. 2025 Jul 16:S0890-8567(25)00337-5. doi: 10.1016/j.jaac.2025.07.007. Online ahead of print.

  PMID: 40681145 DERIVED

• Arns M, Vollebregt MA, Palmer D, Spooner C, Gordon E, Kohn M, Clarke S, Elliott GR, Buitelaar JK. Electroencephalographic biomarkers as predictors of methylphenidate response in attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2018 Aug;28(8):881-891. doi: 10.1016/j.euroneuro.2018.06.002. Epub 2018 Jun 22.

  PMID: 29937325 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Barbara A. Cohen, PhD

  Center for Healing the Human Spirit

  PRINCIPAL INVESTIGATOR

• Harbans Multani, MD

  Shanti Clinical Trials

  PRINCIPAL INVESTIGATOR

• Kamran Fallahpour, PhD

  Brain Resource Center NY

  PRINCIPAL INVESTIGATOR

• Martijn Arns, PhD

  Brainclinics Diagnostics B.V.

  PRINCIPAL INVESTIGATOR

• Mona Ismail, MD

  Brain Resource Center NJ

  PRINCIPAL INVESTIGATOR

• Roger deBeus, PhD

  Skyland Behavioral Health Associates

  PRINCIPAL INVESTIGATOR

• Simon Clarke, MD

  Brain Dynamics Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 11, 2018

Record last verified: 2018-07

Locations

NL (1); AU (1); US (5)