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Trial registered on ANZCTR


Registration number
ACTRN12607000535471
Ethics application status
Approved
Date submitted
10/10/2007
Date registered
18/10/2007
Date last updated
18/10/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Attention deficit hyperactivity disorder (ADHD) Controlled Trial Investigation Of a Non-stimulant (A.C.T.I.O.N).
Scientific title
Randomised Controlled Trial Investigation of Atomoxetine in Attention Deficit Hyperactivity Disorder.
Universal Trial Number (UTN)
Trial acronym
ACTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD) 2440 0
Condition category
Condition code
Mental Health 2543 2543 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2169 0
Treatment: Drugs
Comparator / control treatment
Placebo (starch, silicone), identical capsule/markings.
Control group
Placebo

Outcomes
Primary outcome [1] 3447 0
Primary Outcome 1: Inhibitory Capacity indexed by a computerised (IntegNeuro) 'Stroop'-like test (interference score).
Timepoint [1] 3447 0
Timepoints: baseline, week 6 and week 13
Primary outcome [2] 3448 0
Primary Outcome 2: Emotional Recognition indexed by computerised (IntegNeuro) emotion detection/reaction time test (happy, fear, sad, angry, disgust & neutrual faces).
Timepoint [2] 3448 0
Timepoints: baseline, week 6 and week 13
Secondary outcome [1] 5737 0
Secondary Outcome 1: relationship between primary outcome measures and diagnostic features (externalising and internalising)
Timepoint [1] 5737 0
Timepoints: baseline, week 6 and week 13

Eligibility
Key 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.
Minimum age
8 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Allocation Concealment: Centralised (pair-wise) randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
centralised pairwise randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2690 0
Government body
Name [1] 2690 0
NMHRC Project Grant
Address [1] 2690 0
National Health & Medical Research Council
Country [1] 2690 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital, Sydney West Area Health Service
Address
Hawkesbury Road, Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 2434 0
None
Name [1] 2434 0
Address [1] 2434 0
Country [1] 2434 0

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28103 0
Address 28103 0
Country 28103 0
Phone 28103 0
Fax 28103 0
Email 28103 0
Contact person for public queries
Name 11260 0
Dr. Michael Kohn
Address 11260 0
Faculty of Medicine C29
C/O Children's Hospital Westmead,
The University of Sydney
NSW 2006
Country 11260 0
Australia
Phone 11260 0
02 9845 2446
Fax 11260 0
Email 11260 0
michaek2@chw.edu.au
Contact person for scientific queries
Name 2188 0
Dr. Michael Kohn
Address 2188 0
Faculty of Medicine C29
C/O Children's Hospital Westmead,
The University of Sydney
NSW 2006
Country 2188 0
Australia
Phone 2188 0
02 9845 2446
Fax 2188 0
Email 2188 0
michaek2@chw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results