Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000569404
Ethics application status
Approved
Date submitted
19/04/2016
Date registered
3/05/2016
Date last updated
24/10/2019
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised study comparing the effects of the stimulant medications dexamphetamine and methylphenidate for treating attention deficit hyperactivity disorder (ADHD)
Scientific title
Randomised study comparing the effects of the stimulant medications dexamphetamine and methylphenidate for treating attention deficit hyperactivity disorder (ADHD) during initial dose titration
Secondary ID [1] 289041 0
None
Universal Trial Number (UTN)
U1111-1182-0982
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder 298459 0
Condition category
Condition code
Mental Health 298559 298559 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stimulant medication: dexamphetamine (5mg tablet) or methylphenidate (10mg tablet) taken after breakfast and after recess or lunch, with the dose increased weekly as tolerated according to the following schedule

Child weighing less than 25kg: 0.25 tablets twice daily increasing weekly by increments of 0.25 tablets twice daily to maximum of 1 tablet twice daily
Child weighing 25-35kg: 0.5 tablets twice daily the first week, 1 tablet twice daily the second week, 1.5 tablets in the morning and 1 tablet at midday the 3rd week, 1.5 tablets twice daily the 4th week.
Child weighing more than 35kg: 0.5 tablets twice daily increasing weekly by increments of 0.5 tablets twice daily to maximum of 2 tablet twice daily
Intervention code [1] 294524 0
Treatment: Drugs
Comparator / control treatment
Comparison of dexamphetamine and methylphenidate; no untreated control group
Control group
Active

Outcomes
Primary outcome [1] 298044 0
Change in symptom scores at school using IOWA Conners Rating Scale
Timepoint [1] 298044 0
Baseline and weekly during dose titration
Primary outcome [2] 298045 0
Weight change measured on electronic scales
Timepoint [2] 298045 0
Baseline and 1 month after starting medication
Primary outcome [3] 298046 0
Change in cognitive functioning using Stop Signal Task
Timepoint [3] 298046 0
After titration has established the optimal doses for twice daily administration, the child may attend for one morning and his/her maximum morning dose used in titration will be administered by 3 (for 1.5 tablets) or 4 (for 1 or 2 tablets) half hourly increments, with the Stop Signal Task administered at baseline and half an hour after each increment. This will occur within 18 months of finishing titration.
Secondary outcome [1] 323008 0
Change in parent quality of life using WHOQOL-BREF
Timepoint [1] 323008 0
Baseline and 1 month
Secondary outcome [2] 323170 0
Side effect symptom scale - Barkley
Adverse effects can include insomnia and decreased appetite
Timepoint [2] 323170 0
Baseline and weekly during dose titration

Eligibility
Key inclusion criteria
Previously untreated children with ADHD, with or without oppositional defiant disorder
Minimum age
4 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous treatment with psychotropic medication for ADHD
Child unable to perform computer based cognitive task
Severe psychiatric co-morbidity
Medical contra-indications to stimulant medication

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised 1:1: 6 permutations randomised using dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study relates only to the initial dose titration period; thereafter the medication will be determined by routine clinical means, including discussion with the patient and parent.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number required for 90% power that the lower limit of a 2-sided 90% confidence interval (CI) will be above the non-inferiority limit of 1.5 points of improvement on the IOWA Conners Rating Scale is 48 per group. (This assumes a standard deviation of 2.5 points for the change in score). 48 per group will be rounded up to 50 per group.
Statistical analysis using independent samples t-tests for comparing group data and paired t-tests for paired observations. Significant confounders will be controlled for using linear modeling and correlations will use the Pearson correlation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/05/2016
Actual
24/10/2016
Date of last participant enrolment
Anticipated
1/06/2020
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
100
Accrual to date
76
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5638 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 13096 0
2750 - Penrith

Funding & Sponsors
Funding source category [1] 293413 0
Self funded/Unfunded
Name [1] 293413 0
N/A
Country [1] 293413 0
Primary sponsor type
Government body
Name
Nepean Blue Mountains Local Health District
Address
Derby Street
Penrith
NSW 2750
Country
Australia
Secondary sponsor category [1] 292256 0
None
Name [1] 292256 0
Address [1] 292256 0
Country [1] 292256 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294861 0
Nepean Blue Mountains Human Research Ethics Committee
Ethics committee address [1] 294861 0
The Nepean Hospital
Derby Street
Penrith
NSW 2750
Ethics committee country [1] 294861 0
Australia
Date submitted for ethics approval [1] 294861 0
07/08/2015
Approval date [1] 294861 0
16/11/2015
Ethics approval number [1] 294861 0
15-37 - HREC15/NEPEAN/80

Summary
Brief summary
Dexamphetamine and methylphenidate are used in the treatment of attention deficit hyperactivity disorder (ADHD) but few studies directly compare their efficacy. This randomised study has been designed to compare the efficacy and side effects of dexamphetamine and methylphenidate during initial dose titration for treating ADHD. The dose titration schedule will be allocated by weight (maximum dose 1 tablet twice daily for children up to 25kg body weight, 1.5 tablets twice daily for those 25-35kg and 2 tablets twice daily for those weighing more than 35kg: tablets containing 5mg dexamphetamine or 10mg methylphenidate are conventionally considered equipotent). The dose will be increased weekly (as tolerated) over 4 weeks, aiming to establish the lowest dose that gives maximum improvement in functioning. A rating scale will be requested from the child's teacher describing the child's functioning before starting medication and on each dose. Side effects will be monitored with rating scale and measurement of weight and blood pressure. Cognitive functioning using a simple computer-based test will be assessed unmedicated and on each dose used during titration. At the completion of dose titration the participant's active involvement in the study will cease and medication will either be ceased, continued or changed as clinically indicated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40490 0
Dr Alison Poulton
Address 40490 0
Department of Paediatrics
Nepean Hospital
Derby Street
Penrith
NSW 2750
Country 40490 0
Australia
Phone 40490 0
+61 47343363
Fax 40490 0
Email 40490 0
[email protected]
Contact person for public queries
Name 40491 0
Dr Alison Poulton
Address 40491 0
Department of Paediatrics
Nepean Hospital
Derby Street
Penrith
NSW 2750
Country 40491 0
Australia
Phone 40491 0
+61 47343363
Fax 40491 0
Email 40491 0
[email protected]
Contact person for scientific queries
Name 40492 0
Dr Alison Poulton
Address 40492 0
Department of Paediatrics
Nepean Hospital
Derby Street
Penrith
NSW 2750
Country 40492 0
Australia
Phone 40492 0
+61 47343363
Fax 40492 0
Email 40492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This has not been included in the study design or the ethics approval


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.