Clinical trial NCT02374567: Pharmacovigilance in Gerontopsychiatric Patients
Official title: Pharmacovigilance in Gerontopsychiatric Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Keywords: geriatric psychiatry
pharmacovigilance
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 407
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this 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:

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

Exclusion Criteria:

* Patients that are incapable to give their informed consent and are not under legally authorized custodianship.
* Parallel participation in another clinical trial.

Primary outcomes:
measure: Assessment of frequency and severity of adverse events
timeFrame: Participants will be followed for the duration of hospital stay and the follow-up-visit, an expected average of 6 weeks
Secondary outcomes:
measure: Assessment of cognitive functioning
timeFrame: At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)
measure: Quality of life
timeFrame: At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)
measure: Adverse drug reactions
timeFrame: Continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge
measure: Serum level of substances
timeFrame: 1 day at occurrence of SAR
measure: Electrocardiogram
timeFrame: At baseline visit, at occurrence of SAR and at the final visit (expected average of hospital stay: 4 weeks)
measure: Medication intake
timeFrame: Patients medication intake 2 weeks before hospitalization, continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Bezirkskrankenhaus Augsburg
city: Berlin
country: Germany
facility: Krankenhaus Hedwigshöhe
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: Hannover Medical School
name: Helge Frieling, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: