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

Phase 1

• Conditions: MedDRA version: 9.1 Level: LLT Classification code 10064104 Term: ADHD; MedDRA version: 9.1 Level: LLT Classification code 10020658 Term: Hyperkinetic syndrome; We will conduct a prospective, open-label pilot study of atomoxetine targeted toward symptoms of ADHD in children with learning disabilities and ADHD (Attention Deficit Hyperactivity Disorder).

• Registration Number: EUCTR2008-004827-44-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: 2010-12-07
• Study Completion: 2013-03-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 11

Inclusion Criteria

Principal Inclusion Criteria
1. Children and adolescents of both genders, aged 7-18 years inclusive at the beginning of trial.
Children over 16 should be in full-time education and not expected to leave school within 6 months. Additionally children over 16 will be assessed for their capacity to give consent to participate in the trial using the Mental Capacity Tool (Children over 16 appendix). This tool was designed for use with young adults with intellectual disability, neurodevelopmental or other disorders that might impair their ability to give informed consent. Evidence of potential impairment in capacity includes the diagnosis of learning disability, IQ <70, significant deficits in adaptive functioning, or other signs or symptoms of mental disorder that might compromise capacity to give informed consent. The assessment establishes understanding, retention of information, use of information to make the decision and communication of the decision. These reflect the limbs of the 'capacity test' as defined in the Mental Capacity Act 2005.
We expect that the majority of the over 16 children would have difficulties in showing the necessary understanding in order to consent due to their special needs; in these cases a consultee will be appointed following the procedure described in the Children over 16 appendix.
2. Diagnosis of attention deficit hyperactivity disorder (ADHD)
3. Full-scale IQ 30-69 or age equivalent estimate
4. All participants have failed to respond to methylphenidate or presented with adverse effects that necessitated withdrawal from the study.
5. Their place of residence should be within catchment area.
6. Eligible participants must be in a stabel care situation: Parenting/care history will be reviewed during re-assessment:
a) Care in home
b) Respite Care
c) Residential school placement
7. Informed consent is obtained.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Exclusion Criteria
1. Children currently receiving atomoxetine will not be included.
2. Those who have received atomoxetine in the past, regardless of response, may be included, provided they did not demonstrate frank intolerance.
3. A clear-cut history of intolerance to atomoxetine or concomitant use of MAO inhibitor medication or narrow angle glaucoma represent absolute contradictions to the use of atomoxetine constitute exclusion to the trial.
4. Severe limitation of child’s mobility
5. Child has a dementing or degenerative disorder
6. The presence of poorly controlled or uncontrolled epilepsy
7. History of significant cardiovascular disease
8. Child has a diagnosis of a 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 medication (children on neuleptics for other reasons must be withdrawn from medication for one month before baseline assessment)
11. Child is not on stimulant medication for at least one week
12. Child poses a significant risk of suicidal or homicidal behaviour
13. Children without a full-time school placement that is expected to continue for the next 4 months will not be eligible for the study.
14. Another child in the family and/or in the household currently enrolled in this study.
15. Children residing in a home without a telephone (land line or mobile)
16. There are ongoing child protection concerns

Study & Design

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