ATOM in 22qDS v4

• Research type

  Research Study

• Full title

  OPEN LABEL TRIAL OF ATOMOXETINE FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CHILDREN WITH 22q11.2 DELETION SYNDROME (22qDS)(also called velo-cardio-facial syndrome)

• IRAS ID

  65392

• Contact name

  Emily Simonoff

• Sponsor organisation

  King's College London

• Eudract number

  2010-024551-82

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  In this trial we want to know whether treatment with atomoxetine, a licensed medication for attention deficit hyperactivity disorder (ADHD), improves ADHD symptoms in children and young people with 22qDS (Velo-cardio-facial Syndrome) and ADHD. Children and young people with 22qDS and a diagnosis of ADHD who wish to participate will be invited to an eligibility assessment to see if they meet the trial requirements. Those who meet eligibility criteria and where valid consent is obtained will be randomized. Participating children will all receive atomoxetine; half will be randomly assigned to start medication immediately and half after waiting 8 weeks.Allocation will be open-label. We will review participants regularly to evaluate the medication??s efficacy; reviews involve asking about the child??s behaviour and emotions, a medical examination (including consideration of possible side effects) and completion of standardised questionnaires by parents, teachers and clinicians. At the end of the trial, participants will be given a detailed report about their outcomes on atomoxetine, with recommendations for future symptom management. An optional genetic test to genotype the liver enzymes that metabolise (break down) atomoxetine will be offered to help us understand what effect differences in metabolism have on the effect of treatment.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  12/SC/0032

• Date of REC Opinion

  7 Mar 2012

• REC opinion

  Further Information Favourable Opinion