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

Phase 4

Recruiting

• Conditions: Mental Health - Other mental health disorders; Attention Deficit Hyperactivity Disorder

• Registration Number: ACTRN12616000569404
• Lead Sponsor: epean Blue Mountains Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in symptom scores at school using IOWA Conners Rating Scale [Baseline and weekly during dose titration];Weight change measured on electronic scales [Baseline and 1 month after starting medication];Change in cognitive functioning using Stop Signal Task[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 Measures

Name	Time	Method
Change in parent quality of life using WHOQOL-BREF[Baseline and 1 month];Side effect symptom scale - Barkley<br>Adverse effects can include insomnia and decreased appetite[Baseline and weekly during dose titration]