Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000652077
Ethics application status
Approved
Date submitted
5/08/2010
Date registered
11/08/2010
Date last updated
29/08/2024
Date data sharing statement initially provided
29/08/2024
Date results provided
29/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Imaging the influence and interaction of genes and stimulant medication on attention in Attention Deficit Hyperactivity Disorder (ADHD).
Scientific title
In adolescents with Attention Deficit Hyperactivity Disorder (ADHD), how does methylphenidate compared to placebo, effect Blood Oxygenation Level Dependent (BOLD) response as measured by functional Magnetic Resonance Imaging (fMRI), and how does the response vary with difference in the dopamine transporter (DAT1) gene.
Secondary ID [1] 252387 0
None
Universal Trial Number (UTN)
U1111-1116-4106
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD) 257900 0
Condition category
Condition code
Mental Health 258060 258060 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a crossover trial. Participants will take a single dose of methylphenidate (20mg capsule) in one session, and a placebo capsule on the other session. Sessions are counterbalanced and conducted exactly 2 weeks apart.
Intervention code [1] 256950 0
Treatment: Drugs
Comparator / control treatment
As above, a single dose placebo (20mg lactose capsule) will be taken on one session, either two weeks after the methylphenidate session or two weeks before.
Control group
Placebo

Outcomes
Primary outcome [1] 258922 0
Changes in Blood Oxygenation Level Dependent (BOLD) response, measured by functional Magnetic Resonance Imaging (fMRI), as a function of medication.
Timepoint [1] 258922 0
Two MRI scanning sessions conducted two weeks apart. A single dose of either methylphenidate or placebo will be taken 90 minutes prior to scanning session.
Primary outcome [2] 258951 0
Changes in Blood Oxygenation Level Dependent (BOLD) response, measured by functional Magnetic Resonance Imaging (fMRI), as a function of DAT1 genotype.
Timepoint [2] 258951 0
Two MRI scanning sessions conducted two weeks apart. A single dose of either methylphenidate or placebo will be taken 90 minutes prior to scanning session.
Secondary outcome [1] 265094 0
Nil
Timepoint [1] 265094 0
Nil

Eligibility
Key inclusion criteria
ADHD (combined type)
Healthy, matched control adolescents (Placebo only)
right handed
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Weight under 35kg
Full scale Intelligence Quotient (FSIQ) >70
Conners Parent Rating Scale (CPRS) >65 for ADHD, <60 for controls
gluten intolerance (due to presence in placebo)
wearing dental braces
no reading disabilities,
no comorbidities, of major depression, Autism Spectrum Disorders, or psychosis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This study will employ a placebo-controlled, double-blind, randomised, cross-over design of the influence of methylphenidate vs placebo on the neural substrates of attention in participants with ADHD. The preparation of the drug dose and placebo dose will be conducted by Dr. Kay Hynes, Senior Pharmacist, Drug Information and Clinical Trials (Royal Children's Hospital (RCH) Pharmacy). Randomisation orders will be provided by A/Prof Bellgrove to the pharamacy at the RCH and then doses dispensed to Dr Silk according to this blind regime.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/08/2010
Actual
6/09/2010
Date of last participant enrolment
Anticipated
Actual
13/07/2012
Date of last data collection
Anticipated
Actual
3/10/2012
Sample size
Target
60
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 257409 0
Government body
Name [1] 257409 0
National Health and Medical Research Council (NHMRC)
Country [1] 257409 0
Australia
Primary sponsor type
Individual
Name
Dr. Tim Silk
Address
Murdoch Childrens Research Institute
Royal Children's Hospital,
Flemington Road Parkville Victoria 3052 Australia
Country
Australia
Secondary sponsor category [1] 256638 0
Individual
Name [1] 256638 0
Ass Prof Mark Bellgrove
Address [1] 256638 0
School of Psychology and Queensland Brain Institute (QBI),
QBI Building (#79)
Upland Road
The University of Queensland
St Lucia, Brisbane 4072
Queensland
Country [1] 256638 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259472 0
Royal Children's Hospital Human Research Ethics
Ethics committee address [1] 259472 0
Ethics committee country [1] 259472 0
Australia
Date submitted for ethics approval [1] 259472 0
14/10/2009
Approval date [1] 259472 0
05/02/2010
Ethics approval number [1] 259472 0
29122B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31483 0
Address 31483 0
Country 31483 0
Phone 31483 0
Fax 31483 0
Email 31483 0
Contact person for public queries
Name 14730 0
Dr Tim Silk
Address 14730 0
Murdoch Childrens Research Institute
Royal Children's Hospital,
Flemington Road Parkville Victoria 3052 Australia
Country 14730 0
Australia
Phone 14730 0
+613 8341 5637
Fax 14730 0
Email 14730 0
tim.silk@mcri.edu.au
Contact person for scientific queries
Name 5658 0
Dr Tim Silk
Address 5658 0
Murdoch Childrens Research Institute
Royal Children's Hospital,
Flemington Road Parkville Victoria 3052 Australia
Country 5658 0
Australia
Phone 5658 0
+613 8341 5637
Fax 5658 0
Email 5658 0
tim.silk@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.