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Randomised study comparing the effects of the stimulant medications dexamphetamine and methylphenidate for treating attention deficit hyperactivity disorder (ADHD)

Randomised study comparing the effects of the stimulant medications dexamphetamine and methylphenidate for treating attention deficit hyperactivity disorder (ADHD) during initial dose titration

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000569404
Enrollment
100
Registered
2016-05-03
Start date
2016-10-24
Completion date
2020-11-18
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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. After dose titration, routine clinic data on the participants will be collected (height, weight, side effects, medication, reasons for medication change) until the completion of 12 months on treatment.

Interventions

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

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

Sponsors

Nepean Blue Mountains Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
4 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

Previously untreated children with ADHD, with or without oppositional defiant disorder

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

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 9, 2026