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

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2010-024551-82-GB
• Date of registration: 14/03/2011
• Prospective Registration: Yes
• Primary sponsor: King's College London
• Public title: This a study using Atomoxetine in children with Attention Deficit Hyperactivity Disorder (ADHD) and a specific deletion in the 22qDS gene.
• Scientific title: OPEN LABEL TRIAL OF ATOMOXETINE FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN CHILDREN WITH 22q11.2 DELETION SYNDROME (22qDS) - Atomoxetine in 22qDS
• Date of first enrolment: 07/03/2012
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024551-82
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: immediate start vs delay of 8 weeks before initiation of treatment; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Contacts

• Name: Professor Emily Simonoff
• Affiliation: Institute of Psychiatry, King's College London

• Name: Professor Emily Simonoff
• Affiliation: Institute of Psychiatry, King's College London

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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]

Intervention(s)

Trade Name: Strattera 10mg
Product Name: Strattera 10mg
Pharmaceutical Form: Capsule, hard
CAS Number: 82248-59-7
Other descriptive name: Atomoxetine Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Trade Name: Strattera 18mg
Product Name: Strattera 18mg
Pharmaceutical Form: Capsule, hard
CAS Number: 82248-59-7
Other descriptive name: Atomoxetine Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-

Trade Name: Strattera 25mg
Product Name: Straterra 25mg
Pharmaceutical Form: Capsule, hard
CAS Number: 82248-59-7
Other descriptive name: Atomoxetine Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Strattera 40mg
Product Name: Straterra 40mg
Pharmaceutical Form: Capsule, hard
CAS Number: 82248-59-7
Other descriptive name: Atomoxetine Hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: Strattera 60mg
Product Name: Straterra 60mg
Pharmaceutical Form: Capsule, hard
CAS Number: 82248-59-7
Other descriptive name: ATOMOXETINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-

Trade Name: Strattera 80mg
Product Name: Straterra 80mg

Primary Outcome(s)

Main Objective: What is the efficacy of atomoxetine in reducing the symptoms of ADHD among children with 22qDS who also have ADHD.

Secondary Objective: What is the adverse effects profile associated with atomoxetine treatment amongst children with 22qDS and ADHD.

Primary end point(s): Reduction in symptoms of hyperactive behaviour (overactivity, poor concentration and impulsivity) as rated by parents and teachers on the ADHD index of the short version of the Conners scale (CRS-S; Conners, 1989).
Baseline ratings will be compared to ratings taken during Week 16.
The proportion of “responders” will be estimated using the following three definitions of a “responder”:
i) At least a 30% decrease in symptoms in week 16 score compared to baseline score based on parent ratings on the ADHD index of the CRS-S
ii) At least a 30% decrease in symptoms in week 16 score compared to baseline score based on teacher ratings on the ADHD index of the CRS-S
iii) Where a child is classified as a responder on the basis of both parent and teacher ratings on the ADHD index of the CRS-S as defined above.
Additionally, participants achieving at least 50% decrease in symptoms will be considered good responders.

Timepoint(s) of evaluation of this end point: 16 weeks

Secondary Outcome(s)

Secondary end point(s): Secondary outcome measures include: parent and teacher hyperactivity scale ratings on the Conners Rating Scales
Clinicians’ ratings of improvement in relation to symptoms and impairment as rated on the Clinical Global Impressions Scale at the end of the trial ("Clinical Global Impressions Scale," 1985))
Changes in other behaviours commonly seen in children with learning disabilities will be evaluated by parent and teacher ratings on the Aberrant Behavior Checklist (Aman, Singh, Stewart, & Field, 1985) at baseline and at week 16.
Adverse events will be primariy recorded using the 'Other Behaviors Questonnaire' at baseline, during tiration and weeks 8, 12, 16

Timepoint(s) of evaluation of this end point: 8 and 16 weeks

Secondary ID(s)

ATOM_22qDS/2011

Source(s) of Monetary Support

King's College London

NIHR Central Commissioning Facility

Secondary Sponsor(s)

South London and Maudsley NHS Foundation Trust

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 14/10/2018
• Date Completed: 22/03/2013
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-024551-82/results