Geriatric Psychiatry and Pharmacovigilance (GAP)

Pharmacovigilance in Gerontopsychiatric Patients

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 Overview

• Status: Unknown
• Conditions: Depression; Schizophrenia; Anxiety Disorders; Dementia; Psychosomatic Disorders

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: Alexandra Kleimann, MD; Phone Number: +495115326559; Email: gap_study@mh-hannover.de

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Krankenhaus Hedwigshöhe
    • Contact: Beirich Susanne; Email: s.beirich@alexius.de
    • Principal Investigator: Hans Gutzmann, MD
  • Brandenburg an der Havel, Germany
    • Recruiting
    • Asklepios Fachklinikum Brandenburg
    • Contact: Felix Hohl-Radke, MD; Phone Number: +49 3381 782156
    • Principal Investigator: Felix Hohl-Radke, MD
  • Hannover, Germany, 30625
    • Recruiting
    • Hannover Medical School
    • Contact: Petra Garlipp, MD; Phone Number: +495115326559; Email: garlipp.petra@mh-hannover.de
    • Principal Investigator: Petra Garlipp, MD
  • Lübben, Germany
    • Recruiting
    • Asklepios Fachklinikum Lübben
    • Contact: Kropp Stefan, MD; Phone Number: +49 3546 29200
    • Principal Investigator: Stefan Kropp, MD
  • Teupitz, Germany
    • Recruiting
    • ASKLEPIOS Fachklinikum Teupitz
    • Principal Investigator: Stefan Kropp, MD
    • Contact: Stefan Kropp; Phone Number: +4933766660

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All inpatients meeting the Inclusion/Exclusion criteria, treated at one of the geriatric psychiatry study sites (one university hospital and four primary care clinics), should be screened.

Description

Inclusion Criteria:

1. Age 65+ years old
2. Inpatients treated at one of the geriatric psychiatry study sites.
3. Signed consent form ( Patient and/or legally authorized custodian)

Exclusion Criteria:

1. Patients that are incapable to give their informed consent and are not under legally authorized custodianship.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Geriatric psychiatric in patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of frequency and severity of adverse events in geriatric psychiatry inpatients under psychopharmacological treatment	Patients will be monitored continuosly during the hospital stay (expected average of 4 weeks) and at follow-up, which is 2 weeks after discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of cognitive functioning	Mini Mental State Exam	At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).
Quality of life		At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).
Adverse drug reactions		Patients will be monitored continuosly during the hospital stay (expected average of 4 weeks) and at follow-up, which is 2 weeks after discharge.
Serum levels of substances		1 day at occurence of SAE
Electrocardiogram		At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).
Medication intake	Before hospitalisation and after discharge by interview, during the hospital stay by patients chart.	Patients medication intake 2 weeks before hospitalisation, continuosly during the hospital stay and at follow-up 2 weeks after discharge will be assessed (expected average of 8 weeks).

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Institut für Arzneimittelsicherheit in der Psychiatrie AMSP e.V.; Asklepios Fachklinikum Brandenburg; Asklepios Fachklinikum Lübben für Psychiatrie, Psychotherapie und Psychosomatik; Asklepios Fachklinikum Teupitz für Psychiatrie; Krankenhaus Hedwigshöhe; Kompetenznetz TDM KJP e.V.
• Investigators: Principal Investigator: Helge Frieling, MD, MHH; Study Director: Sermin Toto, MD, MHH; Study Chair: Stefan Bleich, MD, MHH

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ANTICIPATED): May 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: May 15, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (ESTIMATE): May 21, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 29, 2013
• Last Update Submitted That Met QC Criteria: May 27, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: pharmacovigilance; geriatric psychiatry
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Anxiety Disorders; Somatoform Disorders; Psychophysiologic Disorders
• Other Study ID Numbers: GAP2013; V-15222/68605/2012-2015 (OTHER_GRANT: Federal Institute for Drugs and Medical Devices (BfArM))