Status: Finalised First registered on: 08/07/2014
Last updated on: 31/01/2017
1. Study identification
EU PAS Register NumberEUPAS7034
Official titleOff-label use of neuroleptics and antidepressants and risks of psychostimulant use in ADHD patients during childhood and adolescents
Study title acronymOLUNAR
Study typeObservational study
Brief description of the studyBased on data from statutory health insurance (SHI) providers, the study focuses on the off-label use of antipsychotic and antidepressant drugs in children and adolescents and evaluates the related risks and side effects (first part). Furthermore, the risks of stimulant use in children and adolescents with attention deficit and hyperactivity disorder (ADHD) are investigated (second part).
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Website/Homepagewww.bips.uni-bremen.de
Details of (Primary) lead investigator
Title Dr
Last name Riedel
First name Oliver
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed29/10/201229/10/2012
Start date of data collection16/07/201316/07/2013
Start date of data analysis18/12/201318/12/2013
Date of interim report, if expected12/06/201412/06/2014
Date of final study report31/12/201531/10/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyFederal Institute for Drugs and Medical Devices100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Scholle
First name Oliver
Address line 1Achterstraße 30
Address line 2 
Address line 3 
CityBremen 
Postcode 
CountryGermany
Phone number (incl. country code)004942121856878 
Alternative phone number 
Fax number (incl. country code) 
Email address scholle@bips.uni-bremen.de
Public Enquiries
Title Mr 
Last name Scholle 
First name Oliver 
Address line 1Achterstraße 30 
Address line 2 
Address line 3 
CityBremen 
Postcode 
CountryGermany 
Phone number (incl. country code)004942121856878 
Alternative phone number 
Fax number (incl. country code) 
Email address scholle@bips.uni-bremen.de 
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