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 |
| Secondary identifying numbers | LP0349029 |
- 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
Scientific
Department of Education
Curtin University of Technology
GPO Box U1987
Perth, WA
6845
Australia
| h.jenkins@curtin.edu.au |
Study information
| 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 |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Atomoxetine |
| Primary outcome measure | 1. Cognitive functioning, working memory, verbal ability and cognitive efficiency 2. Executive functioning (teacher and parent ratings) 3. Educational achievement |
| Secondary outcome measures | 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) |
| Overall study start date | 01/11/2006 |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 144 (72 participants with ADHD and 72 control children) |
| 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
6845
Australia
Sponsor information
Australian Research Council (Australia)
Research council
Research council
Department of Education, Science and Training
GPO Box 2702
Canberra, ACT
2601
Australia
| info@arc.gov.au | |
| Website | http://www.arc.gov.au/arc_home/default.htm |
"ROR" |
https://ror.org/05mmh0f86 |
Funders
Funder type
Research council
Australian Research Council (ARC) linkage grant (ref LP0349029), which includes:
No information available
ARC funding (AUD 173,000)
No information available
West Australian Dept of Education (AUD 15,000)
No information available
Association of Independent School of Western Australia (AUD 15,000)
No information available
Westmead Children's Hospital Education Research Institute (AUD19,500)
No information available
Eli Lilly Australia Pty Ltd (AUD 45,000)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
