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Geriatric Psychiatry and Pharmacovigilance (GAP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Hannover Medical School.
Recruitment status was:  Recruiting
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   (Adult, Senior)
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

Locations
Germany
Krankenhaus Hedwigshöhe
Berlin, Germany
Asklepios Fachklinikum Brandenburg
Brandenburg an der Havel, Germany
Hannover Medical School
Hannover, Germany, 30625
Asklepios Fachklinikum Lübben
Lübben, Germany
Asklepios Fachklinikum Teupitz
Teupitz, Germany
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

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:
Disease
Schizophrenia
Dementia
Anxiety Disorders
Psychophysiologic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on December 02, 2016