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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00863499




Registration number
NCT00863499
Ethics application status
Date submitted
17/03/2009
Date registered
18/03/2009
Date last updated
11/07/2018

Titles & IDs
Public title
International Study to Predict Optimised Treatment in Attention Deficit/Hyperactivity Disorder
Scientific title
International Study to Predict Optimised Treatment Response to Short or Long Acting Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder.
Secondary ID [1] 0 0
iSPOT-A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit/Hyperactivity Disorder 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Short Acting Methylphenidate
Treatment: Drugs - Long Acting Methylphenidate

Active Comparator: A - Short Acting methylphenidate

Active Comparator: B - Long Acting Methylphenidate

No Intervention: C - Healthy Controls


Treatment: Drugs: Short Acting Methylphenidate
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.

Treatment: Drugs: Long Acting Methylphenidate
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD.
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
Timepoint [1] 0 0
52 weeks

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

Study design
Purpose of the study
Health Services Research
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
1344
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Brain Dynamics Centre - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
Netherlands
State/province [5] 0 0
Gelderland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BRC Operations Pty. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Deficit/Hyperactivity Disorder.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00863499
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barbara A. Cohen, PhD
Address 0 0
Center for Healing the Human Spirit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00863499