ISRCTN25691213Completed未知
Open label randomised trial of atomoxetine for attention deficit hyperactivity disorder (ADHD) in children with special educational needs
King's College London (UK)0 sites40 target enrollmentStarted: October 7, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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 Child on neuroleptic medication (must be withdrawn for 2 months prior to trial assessment)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
Investigators
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