Condition category
Mental and Behavioural Disorders
Date applied
19/06/2009
Date assigned
07/10/2009
Last edited
15/07/2016
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 Emily Simonoff

ORCID ID

Contact details

Professor of Child and Adolescent Psychiatry
Child and Adolescent Psychiatry
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 5312
e.simonoff@iop.kcl.ac.uk

Additional identifiers

EudraCT number

2008-004827-44

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Open label randomised trial of atomoxetine for attention deficit hyperactivity disorder (ADHD) in children with special educational needs

Acronym

HSEN - ATOM

Study hypothesis

1. What is the efficacy of atomoxetine in reducing the symptoms and features of attention deficit hyperactivity disorder (ADHD) in children with moderate and severe learning disabilities who also have ADHD?
2 What is the adverse effect profile associated with atomoxetine treatment in children with learning disabilities?

Both these questions will be addressed in children who have tried stimulant treatment but for whom there is either inadequate symptomatic improvement or unacceptable adverse effects.

Ethics approval

South East Multicentre Research Ethics Committee approved on the 22/10/2008, ref: 08/H1102/86

Study design

Randomised open label trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Attention deficit hyperactivity disorder (ADHD), mental retardation (intellectual disability)

Intervention

40 children between ages 7 and 15 years with moderate-severe learning disability and hyperkinetic disorder will be invited to take part in a open label trial of atomoxetine lasting 16 weeks. Medication dosage for atomoxetine will be individually optimised, balancing reduction in hyperkinetic symptoms against side effects.

Participants will be given daily doses of atomoxetine orally that will be titrated up to a therapeutic dose over a period of two weeks. Initially atomoxetine 0.5 mg/kg (starting dose) will be prescribed for one week, followed by a week of 0.8 mg/kg (low dose). A usual dose of atomoxetine 1.2 mg/kg daily will be carried on after two weeks. Selection of optimal dose will be based on adverse effects and behavioural response. For participants showing less than "much improvement" on the CGI-Improvement (CGI-I) scale at the end of week 8 without presenting adverse effects, may have a further dose increase to 1.4 mg/kg/day (high dose).

Treatment response will be determined by comparing baseline behaviour with that at the end of the 16 weeks. The trial will end at 16 weeks post-randomisation.

Intervention type

Drug

Phase

Not Applicable

Drug names

Atomoxetine

Primary outcome measures

Conners parent and teachers questionnaires, short form: ADHD and hyperactivity indices (parent and teacher), measured at baseline and week 16.

Secondary outcome measures

Measured at baseline and week 16:
1. Adverse events (other behaviours questionnaire plus any others noted)
2. Aberrant Behaviour Checklist
3. Developmental Behaviour Questionnaire
4. Clinical Global Impressions Scale

Overall trial start date

01/08/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 7 - 15 years, either sex
2. Diagnosis of attention deficit hyperactivity disorder (ADHD)
3. Full-scale intelligence quotient (IQ) 30 - 69 or age equivalent estimate
4. Did not respond to methylphenidate either at high dose or because dose limited by unacceptable adverse effects
5. Living in catchment area of one of the participating centres
6. Child in stable care situation
7. Child regularly attending school (more than 75% of last school term)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Child currently taking atomoxetine
2. A clear-cut history of intolerance to atomoxetine or concomitant use of monoamine oxidase (MAO) medication or narrow angle glaucoma that represent absolute contradictions to the use of atomoxetine
3. Severe limitation of child's mobility
4. Presence of a degenerative disorder
5. Medical conditions that may preclude the use of atomoxetine or may confound outcome measures, including:
5.1. Poorly controlled or uncontrolled epilepsy
5.2. History of significant cardiovascular disease
5.3. History of psychotic, bipolar or severe obsessive compulsive disorder
6. Child on neuroleptic medication (must be withdrawn for 2 months prior to trial assessment)
7. Child poses a significant risk of suicidal or homicidal behaviour
8. Another child in the family/household already enrolled in this study
9. Ongoing child protection concerns

Recruitment start date

01/08/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Professor of Child and Adolescent Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

Kings College London (UK)

Sponsor details

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 5312
g.dale@iop.kcl.ac.uk

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK) - Program Grant for Applied Research (PGfAR)

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

15/07/2016: No publications found, verifying study status with principal investigator.