Pharmacovigilance in gerontopsychiatric patients (GAP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/4170
• EU PAS number:
  EUPAS3953
• Study ID:
  4170
• Official title and acronym:
  Pharmacovigilance in gerontopsychiatric patients (GAP)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The purpose of this observational multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment.The aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises.To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites.At Baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ECG will be assessed.Afterwards patients are visited weekly and screened for possible adverse drug reactions. All adverse drug reactions will be coded in the MedDRA-system.In case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. Drug combinations will be analysed using an established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible adverse drug reactions are documented continually.2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Hannover Medical School (MHH)

Asklepios Fachklinikum Teupitz Teupitz, Germany, Asklepios Fachklinikum Lübben Lübben, Germany, Asklepios Fachklinikum Brandenburg Brandenburg an der Havel, Germany, Krankenhaus Hedwigshöhe Berlin, Germany, Medizinische Hochschule Hannover Hannover, Germany

Networks

AMSP Network (AMSP)

Austria

Germany

Switzerland

Kompetenznetz TDM KJP e.V.

Study timelines

Date when funding contract was signed

Actual: 24/10/2012

Study start date

Planned: 21/05/2013

Actual: 21/05/2013

Data analysis start date

Planned: 15/05/2015

Date of final study report

Planned: 31/12/2015

Sources of funding

Other

More details on funding

Federal Institute for Drugs and Medical Devices, Hannover Medical School

Regulatory

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