Atomoxetine for attention deficit hyperactivity disorder (ADHD) in children with special educational needs
| ISRCTN | ISRCTN25691213 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25691213 |
| EudraCT/CTIS number | 2008-004827-44 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/06/2009
- Registration date
- 07/10/2009
- Last edited
- 12/06/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Dr Emily Simonoff
Scientific
Scientific
Professor of Child and Adolescent Psychiatry
Child and Adolescent Psychiatry
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 5312 |
|---|---|
| e.simonoff@iop.kcl.ac.uk |
Study information
| Study design | Randomised open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Open label randomised trial of atomoxetine for attention deficit hyperactivity disorder (ADHD) in children with special educational needs |
| Study 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(s) | South East Multicentre Research Ethics Committee, 22/10/2008, ref: 08/H1102/86 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Atomoxetine |
| Primary outcome measure | 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 study start date | 01/08/2009 |
| Overall study end date | 31/12/2010 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 40 |
| 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 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
- England
- United Kingdom
Study participating centre
Institute of Psychiatry
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Phone | +44 (0)20 7848 5312 |
|---|---|
| g.dale@iop.kcl.ac.uk | |
| Website | http://www.iop.kcl.ac.uk/ |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Program Grant for Applied Research (PGfAR)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
12/06/2017: The trial closed due to insufficient recruitment.
