Attention Deficit/Hyperactivity DisorderPhase 4NCT00863499
International Study to Predict Optimised Treatment in Attention Deficit/Hyperactivity Disorder
A Phase 4 study testing Short Acting Methylphenidate and Long Acting Methylphenidate in people with Attention Deficit/Hyperactivity Disorder, run by BRC Operations Pty. Ltd. at 7 sites in 3 countries.
Trial summary
The aim of the iSPOT-A study is to: 1. identify brain, genetic and cognitive markers of Attention Deficit/Hyperactivity Disorder, and 2. identify brain, genetic and cognitive markers that predict treatment response to short-acting methylphenidate in children and adolescents diagnosed with Attention… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- What is being tested?
- Short Acting Methylphenidate and Long Acting Methylphenidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,344 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Oct 2009to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States5 sites
Skyland Behavioral Health Associates , P.A.
Asheville, North Carolina, 28801
Shanti Clinical Trials
Colton, California, 92324
Brain Resource Center
Englewood Cliffs, New Jersey, 07632
Brain Resource Center
New York, New York, 10023
Center for Healing the Human Spirit
Tarzana, California, 91356
Netherlands1 site
Brainclinics Diagnostics B.V.
Nijmegen, Gelderland, 6524 AD
About this study
Official title: International Study to Predict Optimised Treatment Response to Short or Long Acting Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder.
The aim of the iSPOT-A study is to:
- identify brain, genetic and cognitive markers of Attention Deficit/Hyperactivity Disorder, and
- identify brain, genetic and cognitive markers that predict treatment response to short-acting methylphenidate in children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder.
Read the detailed description
This is a multi-center, open-label effectiveness trial to identify objective indicators of treatment response in ADHD subjects (versus healthy controls) using cognitive and brain function measures, brain structure and genetic measures in subjects diagnosed with ADHD.
At least 672 naïve and treatment experienced subjects with ADHD will be enrolled from approximately 10 primary care centers. These patients are to be outpatients.
In addition, up to 672 healthy (non-ADHD) control subjects will be recruited who match the enrolled ADHD subjects in race, age, gender and years of education.
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Being tested
- Short Acting Methylphenidate, Long Acting Methylphenidate
- Keywords
- Attention Deficit/Hyperactivity Disorder, Attention Deficit Disorder, ADHD, ADD, iSPOT
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Acting MethylphenidateDrug
Also called • Ritalin, • Ritalina, • Attenta, • Methylin
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.
Long Acting MethylphenidateDrug
Also called • Concerta, • Metadate CD, • Methylin ER, • Ritalin LA
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Short Acting methylphenidate Receives: Drug: Short Acting Methylphenidate |
| B | Active comparator | Long Acting Methylphenidate Receives: Drug: Long Acting Methylphenidate |
| C | No intervention | Healthy Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD.
Measured: 6 weeks
Secondary outcomes (1)
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BRC Operations Pty. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara A. Cohen, PhD, Principal investigator, Center for Healing the Human SpiritHarbans Multani, MD, Principal investigator, Shanti Clinical TrialsKamran Fallahpour, PhD, Principal investigator, Brain Resource Center NYMartijn Arns, PhD, Principal investigator, Brainclinics Diagnostics B.V.Mona Ismail, MD, Principal investigator, Brain Resource Center NJRoger deBeus, PhD, Principal investigator, Skyland Behavioral Health AssociatesSimon Clarke, MD, Principal investigator, Brain Dynamics Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863499
- Sponsor's protocol ID
- iSPOT-A
- Status last verified
- Jul 2018
- First submitted
- 17 Mar 2009
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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. 2026 May;65(5):697-711. doi: 10.1016/j.jaac.2025.07.007. Epub 2025 Jul 16.
PubMed 40681145Arns 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.
PubMed 29937325
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Study to Predict Optimised Treatment Response to Short or Long Acting Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder.
- ClinicalTrials.gov ID
- NCT00863499
- Acronym / sponsor ID
- iSPOT-A
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- Attention Deficit/Hyperactivity Disorder, Attention Deficit Disorder, ADHD, ADD, iSPOT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,344 participants (estimated)
- Lead sponsor
- BRC Operations Pty. Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the iSPOT-A study is to:
- identify brain, genetic and cognitive markers of Attention Deficit/Hyperactivity Disorder, and
- identify brain, genetic and cognitive markers that predict treatment response to short-acting methylphenidate in children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder.
Detailed description
This is a multi-center, open-label effectiveness trial to identify objective indicators of treatment response in ADHD subjects (versus healthy controls) using cognitive and brain function measures, brain structure and genetic measures in subjects diagnosed with ADHD.
At least 672 naïve and treatment experienced subjects with ADHD will be enrolled from approximately 10 primary care centers. These patients are to be outpatients.
In addition, up to 672 healthy (non-ADHD) control subjects will be recruited who match the enrolled ADHD subjects in race, age, gender and years of education.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Short Acting MethylphenidateShort Acting methylphenidate |
| B | Active comparator | Drug: Long Acting MethylphenidateLong Acting Methylphenidate |
| C | No intervention | –Healthy Controls |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Acting MethylphenidateAlso: • Ritalin, • Ritalina, • Attenta, • MethylinDosage: 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. | Drug | A |
| Long Acting MethylphenidateAlso: • Concerta, • Metadate CD, • Methylin ER, • Ritalin LADosage: 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. | Drug | B |
Primary outcome
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD.
Time frame: 6 weeks
1 secondary outcome
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Derived from this study: PubMed 40681145Leikauf 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. 2026 May;65(5):697-711. doi: 10.1016/j.jaac.2025.07.007. Epub 2025 Jul 16.
- Derived from this study: PubMed 29937325Arns 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara A. Cohen, PhD principal investigator
Center for Healing the Human Spirit
Harbans Multani, MD principal investigator
Shanti Clinical Trials
Kamran Fallahpour, PhD principal investigator
Brain Resource Center NY
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Short Acting Methylphenidate and Long Acting Methylphenidate in people with Attention Deficit/Hyperactivity Disorder, run by BRC Operations Pty. Ltd. at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00863499, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.