Geriatric Psychiatry and Pharmacovigilance

Summary

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.

Conditions

• Dementia
• Depression
• Schizophrenia
• Psychosomatic Disorders
• Anxiety Disorders

Sponsors & Collaborators

• Institut für Arzneimittelsicherheit in der Psychiatrie AMSP e.V.

  collaborator UNKNOWN

• Asklepios Fachklinikum Brandenburg

  collaborator UNKNOWN

• Asklepios Fachklinikum Lübben für Psychiatrie, Psychotherapie und Psychosomatik

  collaborator UNKNOWN

• Asklepios Fachklinikum Teupitz für Psychiatrie

  collaborator UNKNOWN

• Krankenhaus Hedwigshöhe

  collaborator UNKNOWN

• Kompetenznetz TDM KJP e.V.

  collaborator UNKNOWN

• Hannover Medical School

  lead OTHER

Principal Investigators

• Helge Frieling, MD · MHH

• Sermin Toto, MD · MHH

• Stefan Bleich, MD · MHH

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2015-05-31

Completion

2015-12-31

Countries

• Germany

Study Locations