Attention Deficit Hyperactivity DisorderPhase 4NCT00216918
Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
A Phase 4 study testing Atomoxetine Hydrochloride in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the change in neuropsychological status from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Atomoxetine Hydrochloride
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 10 years 6 months of age at Visit 1 so that all testing will be completed before the child reaches age 11.
- Patients must have moderately severe symptoms of ADHD.
- Patients must be able to swallow study drug capsules.
- 1) Control subjects must be assessed to be not diagnosed with a psychiatric disorder or a medically significant disorder
Who cannot join
- Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.
- Patients must not be home-schooled.
- Controls:
- Subjects will be recruited by the investigator, age and gender-matched to the atomoxetine-treated patients.
- 1) Subjects must not be home-schooled.
Trial locations and contacts
1 site in 1 country.
Canada1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Québec, Quebec, G1R 2W8
About this study
Official title: An Open-Label Pilot Study of Atomoxetine Hydrochloride to Evaluate Neuropsychological Function in Children Ages 6 to 10 Years With Attention-Deficit/Hyperactivity Disorder.
The purpose of this study is to evaluate the change in neuropsychological status from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Atomoxetine Hydrochloride
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atomoxetine HydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The neuropsychological status in five domains as measured by the change in the NEPSY from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.
Secondary outcomes (4)
Assess changes in executive function and attention;Compare changes in neuropsychological status in a normal control group, gender and age matched to atomoxetine-treated patients at baseline and 6 months
Efficacy of atomoxetine after 2 and 6 months, or endpoint from baseline;Assess the correlation of change from baseline to 6 months, or at study discontinuation, in ADHD symptoms with change from baseline in the neuropsychological functioning
Assess the relationships of change from baseline to approximately 2 and 6 months, or endpoint in the core symptoms of ADHD with the changes in functional outcomes as assessed by the WFIRS-P
Examine the French language version of the WFIRS-P questionnaire's psychometric properties including internal consistency and responsiveness to change.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216918
- Sponsor's protocol ID
- 9721
- Other IDs
- B4Z-CA-S013
- Status last verified
- Jan 2007
- First submitted
- 20 Sep 2005
- Last updated
- 26 Jan 2007
- Results posted
- No
Publications
Dickson RA, Maki E, Gibbins C, Gutkin SW, Turgay A, Weiss MD. Time courses of improvement and symptom remission in children treated with atomoxetine for attention-deficit/hyperactivity disorder: analysis of Canadian open-label studies. Child Adolesc Psychiatry Ment Health. 2011 May 11;5:14. doi: 10.1186/1753-2000-5-14.
PubMed 21569378
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study of Atomoxetine Hydrochloride to Evaluate Neuropsychological Function in Children Ages 6 to 10 Years With Attention-Deficit/Hyperactivity Disorder.
- ClinicalTrials.gov ID
- NCT00216918
- Acronym / sponsor ID
- 9721
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Jun 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the change in neuropsychological status from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients must have ADHD, be outpatients, who are at least 6 years of age and not more than 10 years 6 months of age at Visit 1 so that all testing will be completed before the child reaches age 11.
- Patients must have moderately severe symptoms of ADHD.
- Patients must be able to swallow study drug capsules.
- 1) Control subjects must be assessed to be not diagnosed with a psychiatric disorder or a medically significant disorder
Key exclusion criteria (5 listed)
- Patients must not have Bipolar disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or seizure disorder.
- Patients must not be home-schooled.
- Controls:
- Subjects will be recruited by the investigator, age and gender-matched to the atomoxetine-treated patients.
- 1) Subjects must not be home-schooled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atomoxetine Hydrochloride | Drug | – |
Primary outcome
The neuropsychological status in five domains as measured by the change in the NEPSY from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.
4 secondary outcomes
Assess changes in executive function and attention;Compare changes in neuropsychological status in a normal control group, gender and age matched to atomoxetine-treated patients at baseline and 6 months
Efficacy of atomoxetine after 2 and 6 months, or endpoint from baseline;Assess the correlation of change from baseline to 6 months, or at study discontinuation, in ADHD symptoms with change from baseline in the neuropsychological functioning
Assess the relationships of change from baseline to approximately 2 and 6 months, or endpoint in the core symptoms of ADHD with the changes in functional outcomes as assessed by the WFIRS-P
Examine the French language version of the WFIRS-P questionnaire's psychometric properties including internal consistency and responsiveness to change.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2007.
- Derived from this study: PubMed 21569378Dickson RA, Maki E, Gibbins C, Gutkin SW, Turgay A, Weiss MD. Time courses of improvement and symptom remission in children treated with atomoxetine for attention-deficit/hyperactivity disorder: analysis of Canadian open-label studies. Child Adolesc Psychiatry Ment Health. 2011 May 11;5:14. doi: 10.1186/1753-2000-5-14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atomoxetine Hydrochloride in people with Attention Deficit Hyperactivity Disorder, run by Eli Lilly and Company at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The neuropsychological status in five domains as measured by the change in the NEPSY from baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5 diagnosed with ADHD.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00216918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2007.