Attention deficit hyperactivity disorder (ADHD), mental retardation (intellectual disability) Mental and Behavioural Disorders Hyperkinetic disorders
Conditions
Interventions
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. Medicatio
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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 Child on neuroleptic medication (must be withdrawn for 2 months prior to trial assessment) 7.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conners parent and teachers questionnaires, short form: ADHD and hyperactivity indices (parent and teacher), measured at baseline and week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed