Pharmacovigilance in Gerontopsychiatric Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hannover Medical School
- Enrollment
- 4,000
- Locations
- 5
- Primary Endpoint
- Assessment of frequency and severity of adverse events in geriatric psychiatry inpatients under psychopharmacological treatment
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Assessment of frequency and severity of adverse events in geriatric psychiatry inpatients under psychopharmacological treatment
Time Frame: 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
- 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).)
- Medication intake(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).)
Investigators
Helge Frieling,MD
Professor Dr. Helge Frieling, Deputy Director of the Department of psychiatry, social psychiatry and psychotherapy
Hannover Medical School