ADHDCOMPLYNCT00540826
Treatment Compliance in Children and Adolescents on ADHD Medication
An observational study of ADHD, run by Eli Lilly and Company at 1 site in Germany.
Trial summary
The primary research objective of this observational study is to evaluate treatment compliance over one year in children and adolescents who are newly initiated on medication approved for the treatment of ADHD in a routine clinical setting. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- Atomoxetine and stimulants (any approved ADHD medication)
- How many people
- 518 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Jun 2009
- Phase
- Observational
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents who are newly initiated on medication approved for the treatment of ADHD in a routine clinical setting. Participating physicians may be office or hospital based psychiatrists and pediatricians throughout Germany.
Who may be able to join
- 6-17 years old
- diagnosis of ADHD according to ICD-10 or DSM-IV criteria
- new initiation onto an approved medication to treat ADHD
Who cannot join
- no specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
Germany1 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.
Bad Homburg, D-61350
About this study
Official title: Treatment Adherence and Compliance in Children and Adolescents on ADHD Medication and Emotional Expression in Clinical Practice
The primary research objective of this observational study is to evaluate treatment compliance over one year in children and adolescents who are newly initiated on medication approved for the treatment of ADHD in a routine clinical setting. Compliance will be assessed using the Pediatric Compliance Self-Rating (PCSR) Instrument. A patient will be considered as compliant at a given visit, if the PCSR score is at least 5, corresponding to taking the medication at least often.
- Conditions
- ADHD
- Being tested
- Atomoxetine, stimulants (any approved ADHD medication)
- 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.
AtomoxetineDrug
Also called Strattera
in-label use
stimulants (any approved ADHD medication)Drug
in-label use
| Study group | Role | What they receive |
|---|---|---|
| A | A: ADHD-patients receiving non-stimulants (e.g. atomoxetine) Receives: Drug: Atomoxetine | |
| B | B: ADHD-patients receiving stimulants Receives: Drug: stimulants (any approved ADHD medication) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startNov 2007
- Study completionJun 2009
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 ADHDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-615-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540826
- Sponsor's protocol ID
- 12067
- Other IDs
- B4Z-SB-B012
- Acronym
- COMPLY
- Status last verified
- Aug 2009
- First submitted
- 5 Oct 2007
- Last updated
- 27 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Dittmann RW, Banaschewski T, Schacht A, Wehmeier PM. Findings from the observational COMPLY study in children and adolescents with ADHD: core symptoms, ADHD-related difficulties, and patients' emotional expression during psychostimulant or nonstimulant ADHD treatment. Atten Defic Hyperact Disord. 2014 Dec;6(4):291-302. doi: 10.1007/s12402-014-0136-z. Epub 2014 Apr 6.
PubMed 24705867
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Adherence and Compliance in Children and Adolescents on ADHD Medication and Emotional Expression in Clinical Practice
- ClinicalTrials.gov ID
- NCT00540826
- Acronym / sponsor ID
- COMPLY / 12067
- Conditions
- ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Oct 2007 (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 primary research objective of this observational study is to evaluate treatment compliance over one year in children and adolescents who are newly initiated on medication approved for the treatment of ADHD in a routine clinical setting. Compliance will be assessed using the Pediatric Compliance Self-Rating (PCSR) Instrument. A patient will be considered as compliant at a given visit, if the PCSR score is at least 5, corresponding to taking the medication at least often.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: AtomoxetineA: ADHD-patients receiving non-stimulants (e.g. atomoxetine) |
| B | – | Drug: stimulants (any approved ADHD medication)B: ADHD-patients receiving stimulants |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents who are newly initiated on medication approved for the treatment of ADHD in a routine clinical setting. Participating physicians may be office or hospital based psychiatrists and pediatricians throughout Germany.
Key inclusion criteria (3 listed)
- 6-17 years old
- diagnosis of ADHD according to ICD-10 or DSM-IV criteria
- new initiation onto an approved medication to treat ADHD
Key exclusion criteria (1 listed)
- no specific exclusion criteria
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 |
|---|---|---|
| AtomoxetineAlso: Stratterain-label use | Drug | A |
| stimulants (any approved ADHD medication)in-label use | Drug | B |
Primary outcome
Not reported in the source record.
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 27 Aug 2009.
- Derived from this study: PubMed 24705867Dittmann RW, Banaschewski T, Schacht A, Wehmeier PM. Findings from the observational COMPLY study in children and adolescents with ADHD: core symptoms, ADHD-related difficulties, and patients' emotional expression during psychostimulant or nonstimulant ADHD treatment. Atten Defic Hyperact Disord. 2014 Dec;6(4):291-302. doi: 10.1007/s12402-014-0136-z. Epub 2014 Apr 6.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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 (1-877-615-4559) or 1-317-615-4559 Mon-Fri 9 AM to 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?
An observational study of ADHD, run by Eli Lilly and Company at 1 site in Germany.
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 3 inclusion and 1 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 27 Aug 2009. 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 Germany. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00540826, 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 27 Aug 2009.