Atomoxetine for attention deficit hyperactivity disorder (ADHD) in children with special educational needs

Not Applicable

Completed

Conditions: Attention deficit hyperactivity disorder (ADHD), mental retardation (intellectual disability)
Mental and Behavioural Disorders
Hyperkinetic disorders

Registration Number: ISRCTN25691213

Lead Sponsor: King's College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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

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 Child on neuroleptic medication (must be withdrawn for 2 months prior to trial assessment)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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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