Not Yet RecruitingPhase 4ACTRN12607000535471

Attention deficit hyperactivity disorder (ADHD) Controlled Trial Investigation Of a Non-stimulant (A.C.T.I.O.N).

Randomised Controlled Trial Investigation of Atomoxetine in Attention Deficit Hyperactivity Disorder.


Sponsor

Westmead Hospital, Sydney West Area Health Service

Enrollment

180 participants

Start Date

Nov 1, 2007

Study Type

Interventional

Conditions

Summary

Attention Deficit Hyperactivity Disorder (ADHD) is defined by marked changes in both cognitive and emotional functions. The majority of medicated ADHD individuals are treated with stimulants (controlled substances). Up to 30% do not respond to stimulant treatment, and in others the potential for abuse remains. Atomoxetine is a recently approved non-stimulant (non-controlled) to treat ADHD, with evidence of clinical effectiveness. Yet, the impact of atomoxetine on objective measures of a range of cognitive and emotional function has not been studied. Several lines of evidence indicate it is effective for these functions. Atomoxetine has been shown to alleviate inhibitory capacity, while stimulants have not. Common disturbances may underlie abnormal inhibitory capacity and impaired emotional recognition in ADHD that is best treated with atomoxetine rather than stimulants. The primary aims of this project are to: (1) Examine the efficacy of a non-stimulant medication (atomoxetine) in ADHD using a randomised controlled design. (2) Demonstrate that atomoxetine has efficacy for both cognitive and emotional functions, assessed using objective tests, with indicators of clinical improvement. The outcomes from this project will be a significant step towards a 'personalised medicine' approach to ADHD, providing clinicians with increased options in the treatment of ADHD. Should atomoxetine prove to be efficacious for stimulant non-responders it would contribute to reducing the significant social and financial burden of this disorder.


Eligibility

Sex: Both males and femalesMin Age: 8 YearssMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is about attention deficit hyperactivity disorder (ADHD) Controlled Trial Investigation Of a Non-stimulant (A.C.T.I.O.N).. It is looking for adults aged 8 to 16 to participate. To join, participants should meet requirements such as: Males and females between the ages of 8 and 16 years, of normal weight and height, with a primary diagnosis of ADHD will be eligible for inclusion in the study. Participants will be guided through the study procedures by the research team and may need to attend scheduled visits.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Phase A: 0.5 mg/kg atomoxetine, oral, once daily for one week; then 1.0 mg/kg atomoxetine, oral, once daily for 5 weeks. One week washout, crossover. Phase B: 6 weeks of identical looking placebo caps

Phase A: 0.5 mg/kg atomoxetine, oral, once daily for one week; then 1.0 mg/kg atomoxetine, oral, once daily for 5 weeks. One week washout, crossover. Phase B: 6 weeks of identical looking placebo capsules. Randomised to receive Phase A or B first.


Locations(1)

Australia

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