Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000059369
Ethics application status
Approved
Date submitted
28/01/2008
Date registered
30/01/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A structural and functional imaging research of children with Attention Deficit Hyperactivity Disorder (ADHD)
Scientific title
Structural and functional imaging maps of children with Attention Deficit Hyperactivity Disorder (ADHD) using Magnetic Resonance Imaging (MRI) scan of the brain and methylphenidate (MPH)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD) 2777 0
Condition category
Condition code
Mental Health 2909 2909 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be scanned by a MRI scanner. The total time of a scan session is about 45 minutes and data of structural and functional images of the subjects’ brains will be collected. In the functional part, the subjects will perform a cognitive task.
Children with ADHD will be scanned twice. About 1 hour before one of the scan sessions, the patients will take a single dose (10 mg) of MPH orally, which is a drug commonly used in the treatment of ADHD. Then the patients will be scanned. (About 1 hour before the other scan session, the patients will take the placebo, which is described in the “Comparator / control treatment” part of the form.)
The order of the two sessions will be counterbalanced across the patients. The interval between the two sessions will be about 1 week, which is thought to be enough for the clearance of the drug.
Intervention code [1] 2516 0
Treatment: Drugs
Comparator / control treatment
About 1 hour before one of the scans, the patients will take the placebo (Vitamin-B6, 10 mg) orally. Then the patients will be scanned.
Healthy controls will be scanned only once, with the same types of imaging data to be collected, but no drug or placebo will be involved.
Control group
Active

Outcomes
Primary outcome [1] 3789 0
Primary Outcome 1: structural imaging results: volume of different brain regions
Timepoint [1] 3789 0
immediately after the scans are finished
Primary outcome [2] 3790 0
Primary Outcome 2: functional imaging results: activation level of different brain regions
Timepoint [2] 3790 0
immediately after the scans are finished
Secondary outcome [1] 6393 0
Accuracy and reaction times of the cognitive task.
The cognitive task is operated with Presentation (a stimulus delivery and experimental control software system for neuroscience, see details in http://www.neurobs.com) on a computer which is connected to the MRI scanner. When the subjects are performing the task, the accuracy and reaction times will be recorded simultaneously by Presentation in the computer used in the experiment.
Timepoint [1] 6393 0
immediately after the scans are finished

Eligibility
Key inclusion criteria
The patients should met the diagnosis of ADHD, which is based on DSM-IV criteria and have a full scale IQ higher than 80 measured by the Wechsler Intelligence Scale for Chinese Children-Revised (WISCC-R).
Minimum age
11 Years
Maximum age
16 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) right-handedness; 2) no lifetime history of head trauma with loss of consciousness; 3) no history of neurological illness or other serious physical diseases; 4) no history of psychiatric disorders including schizophrenia, affective disorders, anxiety, Tourette disorder, pervasive developmental disorder and mental retardation.

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 774 0
China
State/province [1] 774 0

Funding & Sponsors
Funding source category [1] 3033 0
Government body
Name [1] 3033 0
Natural Science Foundation of China
Country [1] 3033 0
China
Primary sponsor type
University
Name
Children Psychiatry Department, Institute of Mental Health, Peking University
Address
Huayuanbeilu Road 51, Haidian District, Beijing 100083, China
Country
China
Secondary sponsor category [1] 2737 0
University
Name [1] 2737 0
State Key Laboratory of Cognitive Neuroscience and Learning, Beijing Normal University
Address [1] 2737 0
Xinjiekouwai Street 19, Xicheng District, Beijing 100875, China
Country [1] 2737 0
China

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 28340 0
Address 28340 0
Country 28340 0
Phone 28340 0
Fax 28340 0
Email 28340 0
Contact person for public queries
Name 11497 0
Xiaohua Cao
Address 11497 0
Huayuanbeilu Road 51, Haidian District, Beijing 100083, China
Country 11497 0
China
Phone 11497 0
+86 10 82801949
Fax 11497 0
Email 11497 0
[email protected]
Contact person for scientific queries
Name 2425 0
Yufeng Wang
Address 2425 0
Huayuanbeilu Road 51, Haidian District, Beijing 100083, China
Country 2425 0
China
Phone 2425 0
+86 10 82801969
Fax 2425 0
Email 2425 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.