Depression Clinical Trial
Official title:
Pharmacovigilance in Gerontopsychiatric Patients
The purpose of this 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.
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