Off-label use of neuroleptics and antidepressants and risks of psychostimulant use in ADHD patients during childhood and adolescents (OLUNAR)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17515
• EU PAS number:
  EUPAS7034
• Study ID:
  17515
• Official title and acronym:
  Off-label use of neuroleptics and antidepressants and risks of psychostimulant use in ADHD patients during childhood and adolescents (OLUNAR)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Based 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).
• Study status:
  Finalised

Research institution and networks

Institutions

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

Study timelines

Date when funding contract was signed

Planned: 29/10/2012

Actual: 29/10/2012

Study start date

Planned: 16/07/2013

Actual: 16/07/2013

Data analysis start date

Planned: 18/12/2013

Actual: 18/12/2013

Date of interim report, if expected

Planned: 12/06/2014

Actual: 12/06/2014

Date of final study report

Planned: 31/12/2015

Actual: 31/10/2015

Sources of funding

Other

More details on funding

Federal Institute for Drugs and Medical Devices

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable