Geriatric Psychiatry and Pharmacovigilance (GAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Hannover Medical School
Sponsor:
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.
Information provided by (Responsible Party):
Helge Frieling,MD, Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01858857
First received: May 15, 2013
Last updated: May 27, 2013
Last verified: May 2013
  Purpose

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.


Condition
Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacovigilance in Gerontopsychiatric Patients

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Assessment of frequency and severity of adverse events in geriatric psychiatry inpatients under psychopharmacological treatment [ Time Frame: Patients will be monitored continuosly during the hospital stay (expected average of 4 weeks) and at follow-up, which is 2 weeks after discharge. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of cognitive functioning [ Time Frame: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks). ] [ Designated as safety issue: No ]
    Mini Mental State Exam

  • Quality of life [ Time Frame: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks). ] [ Designated as safety issue: No ]
  • Adverse drug reactions [ Time Frame: Patients will be monitored continuosly during the hospital stay (expected average of 4 weeks) and at follow-up, which is 2 weeks after discharge. ] [ Designated as safety issue: Yes ]
  • Serum levels of substances [ Time Frame: 1 day at occurence of SAE ] [ Designated as safety issue: Yes ]
  • Electrocardiogram [ Time Frame: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks). ] [ Designated as safety issue: Yes ]
  • Medication intake [ Time Frame: 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). ] [ Designated as safety issue: No ]
    Before hospitalisation and after discharge by interview, during the hospital stay by patients chart.


Estimated Enrollment: 4000
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Geriatric psychiatric in patients

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858857

Contacts
Contact: Alexandra Kleimann, MD +495115326559 gap_study@mh-hannover.de

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

No publications provided

Responsible Party: Helge Frieling,MD, Professor Dr. Helge Frieling, Deputy Director of the Department of psychiatry, social psychiatry and psychotherapy, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01858857     History of Changes
Other Study ID Numbers: GAP2013, V-15222/68605/2012-2015
Study First Received: May 15, 2013
Last Updated: May 27, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
geriatric psychiatry
pharmacovigilance

Additional relevant MeSH terms:
Depression
Schizophrenia
Anxiety Disorders
Disease
Psychophysiologic Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014