Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects: Results from the National Health Survey for Children and Adolescents (KiGGS) (ADDUCE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/6902
• EU PAS number:
  EUPAS4551
• Study ID:
  6902
• Official title and acronym:
  Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects: Results from the National Health Survey for Children and Adolescents (KiGGS) (ADDUCE)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The primary aim of this study is to examine the potential association between the use of methylphenidate and adverse outcomes using data from the German Health Interview and Examination Survey for Children and Adolescents formally conducted by the Robert Koch Institute. The KiGGS dataset is a nationwide, representative cross-sectional health interview and examination survey with a total of 17641 examined children and adolescents aged 0-17 years. The survey was conducted between May 2003 and 2006 in 167 sample points all over Germany. Participants of the survey were medically and physically examined and tested. Three groups will be identified, i) children and adolescents who have an ADHD code and a methylphenidate code (treatment group), ii) children and adolescents who have an ADHD code but do not have a methylphenidate code (ADHD controls), children and adolescents who do not have an ADHD code or methylphenidate code (Non-ADHD controls). The adverse outcomes to be studied include cardiovascular outcomes e.g. blood pressure, pulse, recorded cardiovascular diagnoses, growth outcomes e.g. height and weight, seizures. Propensity scoring methodology will be used in the analysis of these data.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Dundee

United Kingdom

Division of Neuroscience,Medical Research Institute

Networks

EUropean NETwork for HYperkinetic DISorders (EUNETHYDIS)

Study timelines

Date when funding contract was signed

Planned: 01/10/2010

Actual: 29/10/2010

Study start date

Planned: 01/01/2011

Actual: 01/12/2011

Data analysis start date

Planned: 01/08/2012

Actual: 01/10/2012

Date of final study report

Planned: 01/10/2014

Sources of funding

Other

More details on funding

FP7-HEALTH Grant 260576, University Hospital Erlangen

Regulatory

• Was the study required by a regulatory body?:
  Yes