None listed
Conditions
Brief 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.
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 capsules. Randomised to receive Phase A or B first.
Sponsors
Westmead Hospital, Sydney West Area Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
8 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Individuals will not be admitted to the study if any of the following criteria are present: (1) long history of prescribed medications not related to ADHD; (2) current stimulant use; (3) any medical condition or disease that might interfere with the assessments (e.g. hearing impairment) or put them at increased risk when exposed to atomoxetine (e.g., cardiac irregularities); (4) any psychiatric or neurological condition, such as, seizure disorder, bipolar disorder, and schizophrenia (not including ADHD with common comorbidities such as internalising, externalizing and learning disorders); (5) consumption of two or more standard alcoholic drinks per day; (6) other drug abuse or extensive drug use; (7) any experimental drug within the past four months (prior to the study); (8) drug hypersensitivity or anaphylaxis; (9) heavy caffeine use (more than 4 cups of coffee or equivalent per day); (10) users of nicotine; (11) in the opinion of the investigator the subject is unable and/or unlikely to comprehend and follow the study procedures and instructions (12) do not sign informed consent (with parents/guardians) prior to study entry (13) do not agree to participation information and preparation requirements; (14) do not complete the demographic questionnaire; (15) not English literate.
Outcome results
None listed