Atomoxetine-HSEN

• Research type

  Research Study

• Full title

  OPEN LABEL TRIAL OF ATOMOXETINE FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CHILDREN WITH SPECIAL EDUCATIONAL NEEDS

• IRAS ID

  4104

• Sponsor organisation

  King's College London

• Eudract number

  2008-004827-44

• ISRCTN Number

  N/A

• Research summary

  We will conduct a Prospective,open-label trial of atomoxetine in children with learning disabilities (LD) andAttention Deficit Hyperactivity Disorder (ADHD). The aim is to examine ifatomoxetine is associated with improvement in ADHD symptoms in children whofailed to respond or presented with adverse effects on methylphenidate.Atomoxetine could therefore representa second line treatment option in thispopulation. Atomoxetine is a licensed medication for ADHD and will be usedaccording to manufactureris recommendations.risks and inconvenience predicted do not exceed those encountered duringroutine prescription of medication treatment according to clinical guidelines.Eligible subjects for the atomoxetine trial will be identified through aprevious study of methylphenidate (Hyperactivity and Special Educational Needs Study) or through clinical referrals. Wider London and South East England area will beincluded. All visits will be conducted either in a NHS site locally aftergetting approval from R&D or in school settings. Families will be contactedand if they agree to participate, informed consent will be obtained. Children willparticipate in the study for up to 16 weeks. They will be prescribedatomoxetine and be followed up systematically to evaluate both Effectivenessand possible side effects. As atomoxetine is metabolised by a group of liverenzymes that is not fully potent in 5-7% of people, a genetic test for theseenzymes will be offered as an option. Follow-up will include child psychiatrestassessment, medical examination and standardised questionnaires, rated byparents, teachers and clinicians. Participants will be informed about thedetails of trial through an information'sheet. At the end of week 16, the Participants will be given a detailed report about their outcome on atomoxetineand recommendations for their future management. The trial is conducted by King'sCollege London, funded by the Department of Health.

• REC name

  London - South East Research Ethics Committee

• REC reference

  08/H1102/86

• Date of REC Opinion

  22 Oct 2008

• REC opinion

  Further Information Favourable Opinion