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| Name | Class |
|---|---|
| Zentralinstitut für Seelische Gesundheit Mannheim | OTHER |
| Universita degli Studi di Cagliari | UNKNOWN |
| Vadaskert Child and Adolescent Psychiatric Hospital | OTHER |
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The aim of the ADDUCE project is to investigate any adverse effects of methylphenidate (trade name ritalin) on growth, neurological system, psychiatric states and cardiovascular system over a two year period in children and adults.
Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children, affecting approximately 5% children in Europe. Methylphenidate (MPH, trade name ritalin) is the most-commonly prescribed medication for ADHD children; it is also increasingly used in ADHD adults. In 2007, the European Commission requested a referral to the Committee for Medicinal Products for Human Use (CHMP) under Article 31 of Directive 2001/83/EC, as amended, for MPH because of safety concerns. The CHMP concluded that study of the long-term effects of MPH on growth, sexual development, neurological system, psychiatric states and cardiovascular system is needed. In response to the CHMP s concerns, the ADDUCE (Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects) research team has been formed by a consortium of experts in the fields of ADHD, drug safety, neuro-psychopharmacology and cardiovascular research.
The ADDUCE project aims to investigate the long-term adverse effects of MPH on growth, neurological system, psychiatric states and cardiovascular system in children and adults.
Furthermore the ADDUCE team will develop research tools for the evaluation of adverse effects of MPH on cognition and motivation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADHD medicated | Children aged 5-17 years with clinical diagnosis of ADHD and not previously treated with methylphenidate who have an agreement with their physician to begin treatment with methylphenidate. | ||
| ADHD unmedicated controls | Children aged between 5-17 years with clinical diagnosis and not previously treated with methylphenidate who have an agreement with their physician NOT to treat with methylphenidate | ||
| Non-ADHD controls | Any child, including siblings of a child in either the ADHD-medicated or ADHD-unmedicated control group, who is 5-17 years old. These children must have a low rating (<1.5) on the clinician-rated Swanson Nolan and Pelham IV Rating scale (SNAP IV) and not be medicated with with either dexamfetamine or atomoxetine. |
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| Measure | Description | Time Frame |
|---|---|---|
| The height velocity standard deviation score | Child's height velocity-mean height velocity for sex and age / Standard deviation of height velocity for sex and age. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in growth |
|
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Inclusion Criteria:
ADHD-treated group:
ADHD-unmedicated controls:
Non-ADHD controls:
Exclusion Criteria:
All Groups:
Un-medicated ADHD controls:
Non-ADHD controls:
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Attention Deficit Disorder clinic
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| Name | Affiliation | Role |
|---|---|---|
| David Coghill, ' | University of Dundee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentralinstitut fuer seelische gesundheit | Mannheim | Stadtkreis | Germany | |||
| Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27118284 | Derived | Inglis SK, Carucci S, Garas P, Hage A, Banaschewski T, Buitelaar JK, Dittmann RW, Falissard B, Hollis C, Kovshoff H, Liddle E, McCarthy S, Nagy P, Neubert A, Rosenthal E, Sonuga-Barke E, Wong I, Zuddas A, Coghill DC; ADDUCE Consortium. Prospective observational study protocol to investigate long-term adverse effects of methylphenidate in children and adolescents with ADHD: the Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects (ADDUCE) study. BMJ Open. 2016 Apr 26;6(4):e010433. doi: 10.1136/bmjopen-2015-010433. |
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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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| 2 years |
| Changes to the cardiovascular system |
| 2 years |
| Effects on Psychiatric state |
| 2 years |
| Changes in neurological state |
| 2 years |
| Budapest |
| Hungary |
| Universita degli Studi di Cagliari | Cagliari | Sardinia | Italy |
| University of Dundee | Dundee | Tayside | DD1 9SY | United Kingdom |