Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000271202
Ethics application status
Approved
Date submitted
17/03/2009
Date registered
15/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
International Study to Predict Optimised Treatment in Children and Adolescents with Attention Deficit/Hyperactivity Disorder
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
iSPOT-A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit/Hyperactivity Disorder (ADHD) in children and adolescents 4470 0
Condition category
Condition code
Mental Health 4742 4742 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 4214 0
Treatment: Drugs
Comparator / control treatment
Matched healthy subjects not taking medication. Control subjects must not have any psychiatric diagnosis, medical condition, disease or disorder that could interfere with the study assessments, history of brain injury or substance dependence.
Groups will be matched for age, gender and years of education.
Control group
Active

Outcomes
Primary outcome [1] 5610 0
Composite markers from 165 different assessments/variables will be assessed to identify genetic, brain structure/function and cognitive markers (or combination of markers) which predict acute drug treatment response in ADHD. This will be assessed using: The MINI International Neuropsychatric Interview for Children and Adolescents, ADHD Rating Scale IV, Conners Rating Scales - Revised (Long versions - parent and teacher). Web based questionnaire (web-Q), including: Brain Resource Inventory of Social Cognition (BRISC), Depression, Anxiety and Stress Scale (DASS21), Neuroticism, Extraversion, and Openness Five Factor Inventory (NEO-FFI), Paediatric Quality of Life Inventory (PEDS-QL). Psychophysiological assessment (including, respiratory rate, sweat rate, Electroencephalography (EEG) and Event Related Potential) and a Cognitive test battery. Genetic analysis. Structural and functional magnetic resonance imaging (MRI).
Timepoint [1] 5610 0
6 weeks after baseline visit.
Secondary outcome [1] 9441 0
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months. Using Conners Rating Scales - Revised (Long versions - parent and teacher) and Paediatric Quality of Life Inventory (PEDS-QL).
Timepoint [1] 9441 0
Week 52

Eligibility
Key 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.
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1344
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1557 0
2145
Recruitment postcode(s) [2] 1558 0
5042
Recruitment postcode(s) [3] 1559 0
3122
Recruitment outside Australia
Country [1] 1677 0
New Zealand
State/province [1] 1677 0
Auckland
Country [2] 1678 0
United States of America
State/province [2] 1678 0
Rhode Island
Country [3] 1679 0
South Africa
State/province [3] 1679 0
Bryanston
Country [4] 1680 0
Netherlands
State/province [4] 1680 0
Nijmegen
Country [5] 1681 0
United States of America
State/province [5] 1681 0
North Carolina
Country [6] 1682 0
United States of America
State/province [6] 1682 0
California

Funding & Sponsors
Funding source category [1] 4678 0
Commercial sector/Industry
Name [1] 4678 0
Brain Resource Pty Ltd
Country [1] 4678 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Brain Resource Pty Ltd
Address
Level 12, 235 Jones St
Ultimo, NSW, 2007
Country
Australia
Secondary sponsor category [1] 4224 0
None
Name [1] 4224 0
Address [1] 4224 0
Country [1] 4224 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6716 0
Copernicus Group Institutional Review Board (IRB)
Ethics committee address [1] 6716 0
One Triangle Drive, Suite 100
P.O. Box 110605
Research Triangle Park, NC 27709
Ethics committee country [1] 6716 0
United States of America
Date submitted for ethics approval [1] 6716 0
Approval date [1] 6716 0
12/02/2009
Ethics approval number [1] 6716 0
BRA1-09-021

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29391 0
Address 29391 0
Country 29391 0
Phone 29391 0
Fax 29391 0
Email 29391 0
Contact person for public queries
Name 12638 0
Mimma Mason
Address 12638 0
Level 12, 235 Jones Street
Ultimo, NSW 2007
Country 12638 0
Australia
Phone 12638 0
+61 2 9211 7120
Fax 12638 0
Email 12638 0
[email protected]
Contact person for scientific queries
Name 3566 0
Lea Williams, PhD
Address 3566 0
Level 12, 235 Jones Street
Ultimo, NSW 2007
Country 3566 0
Australia
Phone 3566 0
+61 2 9845 8195
Fax 3566 0
Email 3566 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.