This a study using Atomoxetine in children with Attention Deficit Hyperactivity Disorder (ADHD) and a specific deletion in the 22qDS gene.

Phase 1

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD) in children with 22qDS deletion syndrome; MedDRA version: 14.1 Level: LLT Classification code 10064104 Term: ADHD System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2010-024551-82-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-14
• Study Completion: 2013-03-22
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Children and adolescents of both genders, aged 7-17 years inclusive at the beginning of trial, with a genetically confirmed diagnosis of 22qDS.
2. Diagnosis of Attention Deficit Hyperactivity Disorder.
3. Access allowed to medical records
4. Participant is in a stable care situation.
5. Informed consent is obtained.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Children currently receiving atomoxetine will not be included. (Those who have received atomoxetine in the past regardless of response, may be included, provided they did not demonstrate frank intolerance, i.e. moderate to severe adverse effects at low doses).
2. A clear-cut history of intolerance to atomoxetine (defined as serious or moderate adverse events at very low doses eg 10mgs o.d)
3. Concomitant use of MAO inhibitor or narrow angle glaucoma (due to increased risk of mydriasis) represent absolute contradictions to the use of atomoxetine and constitute exclusion to the trial. MAOI use within the last 2 weeks or other drugs that affect brain monamine concentrations are also an exclusion
4. Severe limitation of mobility
5. Dementia or degenerative disorder
6. Poorly controlled or uncontrolled epilepsy
7. Presence of significant cardiovascular disease (Medical notes will be reviewed by a consulant paediatrician and further investigations undertaken, if necessary, to exclude any reason for inclusion).
8. Psychotic disorder or bipolar disorder.
9. Child has severe obsessive-compulsive disorder severe enough to require special treatment.
10. Child is being treated with neuroleptic or stimulant medication (children have to be off neuroleptic medication for at least 1 month and 1 week off stimulant medication prior to randomisation)
11. Child poses a significant risk of suicidal or homicidal behaviour
12. Children without a full-time school/college placement that is expected to continue for the next 4 months.
13. Another child the in family and/or household currently enrolled in this study
14. Children residing in a home without a telephone (land line or mobile)
15. Ongoing child protection concerns
16. For female participants, pregnancy or not wishing to have a pregnancy test at baseline, will be an exclusion criterion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified