Clinical trial NCT01858857: Geriatric Psychiatry and Pharmacovigilance
Official title: Pharmacovigilance in Gerontopsychiatric Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Keywords: geriatric psychiatry
pharmacovigilance
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Institut für Arzneimittelsicherheit in der Psychiatrie AMSP e.V.
name: Asklepios Fachklinikum Brandenburg
name: Asklepios Fachklinikum Lübben für Psychiatrie, Psychotherapie und Psychosomatik
name: Asklepios Fachklinikum Teupitz für Psychiatrie
name: Krankenhaus Hedwigshöhe
name: Kompetenznetz TDM KJP e.V.
First posted: 2013-05-21
Enrollment: 4000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Assessment of frequency and severity of adverse events in geriatric psychiatry inpatients under psychopharmacological treatment
timeFrame: 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:
measure: Assessment of cognitive functioning
timeFrame: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).
measure: Quality of life
timeFrame: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).
measure: Adverse drug reactions
timeFrame: Patients will be monitored continuosly during the hospital stay (expected average of 4 weeks) and at follow-up, which is 2 weeks after discharge.
measure: Serum levels of substances
timeFrame: 1 day at occurence of SAE
measure: Electrocardiogram
timeFrame: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).
measure: Medication intake
timeFrame: 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).
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Krankenhaus Hedwigshöhe
city: Brandenburg an der Havel
country: Germany
facility: Asklepios Fachklinikum Brandenburg
city: Hannover
country: Germany
facility: Hannover Medical School
city: Lübben
country: Germany
facility: Asklepios Fachklinikum Lübben
city: Teupitz
country: Germany
facility: Asklepios Fachklinikum Teupitz
Study officials:
affiliation: MHH
name: Helge Frieling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MHH
name: Sermin Toto, MD
role: STUDY_DIRECTOR
affiliation: MHH
name: Stefan Bleich, MD
role: STUDY_CHAIR
References: