Geriatric Psychiatry and Pharmacovigilance

NCT01858857 | Unknown DMC

• 2 other identifiers: GAP2013V-15222/68605/2012-2015
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

geriatric psychiatry; pharmacovigilance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assessment of cognitive functioning

  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).

Study Arms (1)

Geriatric psychiatric in patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hannover Medical School: lead
• Institut für Arzneimittelsicherheit in der Psychiatrie AMSP e.V.: collaborator
• Asklepios Fachklinikum Brandenburg: collaborator
• Asklepios Fachklinikum Lübben für Psychiatrie, Psychotherapie und Psychosomatik: collaborator
• Asklepios Fachklinikum Teupitz für Psychiatrie: collaborator
• Krankenhaus Hedwigshöhe: collaborator
• Kompetenznetz TDM KJP e.V.: collaborator

Study Sites (5)

Krankenhaus Hedwigshöhe

Berlin, Germany

RECRUITING

Asklepios Fachklinikum Brandenburg

Brandenburg, Germany

RECRUITING

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

Asklepios Fachklinikum Lübben

Lubin, Germany

RECRUITING

Asklepios Fachklinikum Teupitz

Teupitz, Germany

RECRUITING

MeSH Terms

Conditions

Dementia; Depression; Schizophrenia; Psychophysiologic Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Helge Frieling, MD

  MHH

  PRINCIPAL INVESTIGATOR

• Sermin Toto, MD

  MHH

  STUDY DIRECTOR

• Stefan Bleich, MD

  MHH

  STUDY CHAIR

Central Study Contacts

Alexandra Kleimann, MD

CONTACT

+495115326559; gap_study@mh-hannover.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Helge Frieling, Deputy Director of the Department of psychiatry, social psychiatry and psychotherapy

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

DE (5)