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Geriatric Psychiatry and Pharmacovigilance

NCT ID: NCT01858857

Last Updated: 2013-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dementia Depression Schizophrenia Psychosomatic Disorders Anxiety Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Geriatric psychiatric in patients

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut für Arzneimittelsicherheit in der Psychiatrie AMSP e.V.

UNKNOWN

Sponsor Role collaborator

Asklepios Fachklinikum Brandenburg

UNKNOWN

Sponsor Role collaborator

Asklepios Fachklinikum Lübben für Psychiatrie, Psychotherapie und Psychosomatik

UNKNOWN

Sponsor Role collaborator

Asklepios Fachklinikum Teupitz für Psychiatrie

UNKNOWN

Sponsor Role collaborator

Krankenhaus Hedwigshöhe

UNKNOWN

Sponsor Role collaborator

Kompetenznetz TDM KJP e.V.

UNKNOWN

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Helge Frieling,MD

Professor Dr. Helge Frieling, Deputy Director of the Department of psychiatry, social psychiatry and psychotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helge Frieling, MD

Role: PRINCIPAL_INVESTIGATOR

MHH

Sermin Toto, MD

Role: STUDY_DIRECTOR

MHH

Stefan Bleich, MD

Role: STUDY_CHAIR

MHH

Locations

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Krankenhaus Hedwigshöhe

Berlin, , Germany

Site Status RECRUITING

Asklepios Fachklinikum Brandenburg

Brandenburg, , Germany

Site Status RECRUITING

Hannover Medical School

Hanover, , Germany

Site Status RECRUITING

Asklepios Fachklinikum Lübben

Lubin, , Germany

Site Status RECRUITING

Asklepios Fachklinikum Teupitz

Teupitz, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Alexandra Kleimann, MD

Role: CONTACT

[email protected]
+495115326559

Facility Contacts

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Beirich Susanne

Role: primary

[email protected]

Felix Hohl-Radke, MD

Role: primary

+49 3381 782156

Petra Garlipp, MD

Role: primary

[email protected]
+495115326559

Kropp Stefan, MD

Role: primary

+49 3546 29200

Stefan Kropp

Role: primary

+4933766660

Other Identifiers

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V-15222/68605/2012-2015

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GAP2013

Identifier Type: -

Identifier Source: org_study_id

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