Geriatric Psychiatry and Pharmacovigilance (GAP)
Recruitment status was: Recruiting
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:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Pharmacovigilance in Gerontopsychiatric Patients|
- 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. ]
- Assessment of cognitive functioning [ Time Frame: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks). ]Mini Mental State Exam
- Quality of life [ Time Frame: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks). ]
- Adverse drug reactions [ 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. ]
- Serum levels of substances [ Time Frame: 1 day at occurence of SAE ]
- Electrocardiogram [ Time Frame: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks). ]
- Medication intake [ Time Frame: 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). ]Before hospitalisation and after discharge by interview, during the hospital stay by patients chart.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
|Geriatric psychiatric in patients|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01858857
|Asklepios Fachklinikum Brandenburg|
|Brandenburg an der Havel, Germany|
|Hannover Medical School|
|Hannover, Germany, 30625|
|Asklepios Fachklinikum Lübben|
|Asklepios Fachklinikum Teupitz|
|Principal Investigator:||Helge Frieling, MD||MHH|
|Study Director:||Sermin Toto, MD||MHH|
|Study Chair:||Stefan Bleich, MD||MHH|