Condition category
Mental and Behavioural Disorders
Date applied
02/11/2006
Date assigned
20/11/2006
Last edited
20/11/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Heather Jenkins

ORCID ID

Contact details

Department of Education
Curtin University of Technology
GPO Box U1987
Perth
WA
6845
Australia
h.jenkins@curtin.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LP0349029

Study information

Scientific title

Acronym

LAtADHD

Study hypothesis

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

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.

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

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Attention Deficit Hyperactivity Disorder

Intervention

Administration of atomoxetine for 26 weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

Atomoxetine

Primary outcome measures

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 trial start date

01/11/2006

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

144 (72 participants with ADHD and 72 control children)

Participant exclusion criteria

1. A history of bipolar or psychotic disorder
2. Tourette’s 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

Recruitment start date

01/11/2006

Recruitment end date

01/11/2007

Locations

Countries of recruitment

Australia

Trial participating centre

Department of Education
Perth, WA
6845
Australia

Sponsor information

Organisation

Australian Research Council (Australia)

Sponsor details

Department of Education
Science and Training
GPO Box 2702
Canberra
ACT
2601
Australia
info@arc.gov.au

Sponsor type

Research council

Website

http://www.arc.gov.au/arc_home/default.htm

Funders

Funder type

Research council

Funder name

Australian Research Council (ARC) linkage grant (ref LP0349029), which includes:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

ARC funding (AUD 173,000)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

West Australian Dept of Education (AUD 15,000)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Association of Independent School of Western Australia (AUD 15,000)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Westmead Children's Hospital Education Research Institute (AUD19,500)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Eli Lilly Australia Pty Ltd (AUD 45,000)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes