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Clinical Trials/ISRCTN25691213
ISRCTN25691213
Completed
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 enrollmentOctober 7, 2009
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ConditionsAttention deficit hyperactivity disorder (ADHD), mental retardation (intellectual disability)Mental and Behavioural DisordersHyperkinetic disorders

Overview

Phase
未知
Intervention
Not specified
Conditions
Attention deficit hyperactivity disorder (ADHD), mental retardation (intellectual disability)
Sponsor
King's College London (UK)
Enrollment
40
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 7, 2009
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
King's College London (UK)

Eligibility 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

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 Child on neuroleptic medication (must be withdrawn for 2 months prior to trial assessment)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

Outcomes

Primary Outcomes

Not specified

Similar Trials

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