NCT01470261

Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,398 (actual)
• Sponsor: NHS Tayside · Other Government
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2011-11-11
• Last updated: 2016-09-21

Locations

4 sites across 4 countries: Germany, Hungary, Italy, United Kingdom