Geriatric Psychiatry and Pharmacovigilance

Depression Clinical Trial

— GAP  

Official title:

Pharmacovigilance in Gerontopsychiatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01858857
• Other study ID #: GAP2013
• Secondary ID: V-15222/68605/20
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2013
• Last updated: May 27, 2013
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2013
• Source: Hannover Medical School
• Contact: Alexandra Kleimann, MD
• Phone: +495115326559
• Email: gap_study[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety Disorders
• Dementia
• Depression
• Disease
• Psychophysiologic Disorders
• Psychosomatic Disorders
• Schizophrenia

Locations

Country	Name	City	State
Germany	Krankenhaus Hedwigshöhe	Berlin
Germany	Asklepios Fachklinikum Brandenburg	Brandenburg an der Havel
Germany	Hannover Medical School	Hannover
Germany	Asklepios Fachklinikum Lübben	Lübben
Germany	Asklepios Fachklinikum Teupitz	Teupitz

Sponsors (7)

Lead Sponsor	Collaborator
Hannover Medical School	Asklepios Fachklinikum Brandenburg, Asklepios Fachklinikum Lübben für Psychiatrie, Psychotherapie und Psychosomatik, Asklepios Fachklinikum Teupitz für Psychiatrie, Institut für Arzneimittelsicherheit in der Psychiatrie AMSP e.V., Kompetenznetz TDM KJP e.V., Krankenhaus Hedwigshöhe

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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).	No
Secondary	Quality of life		At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).	No
Secondary	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.	Yes
Secondary	Serum levels of substances		1 day at occurence of SAE	Yes
Secondary	Electrocardiogram		At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).	Yes
Secondary	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).	No