A prospective Longitudinal trial of the effect of Atomoxetine on cognitive, educational, behavioural, social and emotional wellbeing in students with Attention Deficit Hyperactivity Disorder

ISRCTN	ISRCTN05214203
DOI	https://doi.org/10.1186/ISRCTN05214203
Protocol serial number	LP0349029
Sponsor	Australian Research Council (Australia)
Funders	Australian Research Council (ARC) linkage grant (ref LP0349029), which includes:, ARC funding (AUD 173,000), West Australian Dept of Education (AUD 15,000), Association of Independent School of Western Australia (AUD 15,000), Westmead Children's Hospital Education Research Institute (AUD19,500), Eli Lilly Australia Pty Ltd (AUD 45,000)

Submission date: 02/11/2006
Registration date: 20/11/2006
Last edited: 20/11/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Heather Jenkins
Scientific

Department of Education
Curtin University of Technology
GPO Box U1987
Perth, WA
6845
Australia

Email	h.jenkins@curtin.edu.au

Study information

Primary study design	Interventional
Study design	Prospective longitudinal study, with a control group of children without ADHD, matched for age and gender and within the same school class as the children with ADHD
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	LAtADHD
Study objectives	It is hypothesised that over a period of 26 weeks' administration of atomoxetine, students with Attention Deficit Hyperactivity Disorder (ADHD) will demonstrate: 1. Improvement in the cognitive functions of working memory, verbal ability and cognitive efficiency 2. Improved executive functioning capacity 3. Improvement in their educational achievements in reading, mathematics, spelling and written compostion. 4.Improvement in their depression and anxiety ratings. 5. Improvement in their social skills and perceptions of the classroom learning environment.
Ethics approval(s)	The study has been approved by the Curtin University Human Research Ethics Committee, (Approval Ref No. 28/2005), and complies with all requirements of the Australian National Health and Medical Research Committee.
Health condition(s) or problem(s) studied	Attention Deficit Hyperactivity Disorder
Intervention	Administration of atomoxetine for 26 weeks.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Atomoxetine
Primary outcome measure(s)	1. Cognitive functioning, working memory, verbal ability and cognitive efficiency 2. Executive functioning (teacher and parent ratings) 3. Educational achievement
Key secondary outcome measure(s)	1. Depression (child, parent, teacher ratings) 2. Anxiety (child and parent ratings) 3. Social skills (teacher and parent ratings) 4. Perceptions of learning environment (child ratings)
Completion date	01/11/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	15 Years
Sex	All
Target sample size at registration	144
Key inclusion criteria	1. Boys and girls aged seven to 15 years 2. Meet the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for ADHD, as determined by the referring paediatrician or child psychiatrist 3. Participants are naive to atomoxetine medication
Key exclusion criteria	1. A history of bipolar or psychotic disorder 2. Tourettes syndrome 3. Substance abuse 4. Serious medical illness 5. Intellectual disability (Intelligence Quotient [IQ] less than 70) 6. Pregnancy 7. Non compliance with research protocol
Date of first enrolment	01/11/2006
Date of final enrolment	01/11/2007

Locations

Countries of recruitment

Australia

Study participating centre

Department of Education

Perth, WA
6845
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan