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| ID | Type | Description | Link |
|---|---|---|---|
| B4Z-SB-B012 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | A: ADHD-patients receiving non-stimulants (e.g. atomoxetine) |
| |
| B | B: ADHD-patients receiving stimulants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | in-label use |
|
|
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24705867 | Derived | 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. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| D000697 | Central Nervous System Stimulants |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D045505 | Physiological Effects of Drugs |
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| stimulants (any approved ADHD medication) |
| Drug |
in-label use |
|
| Germany |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |