Pharmacovigilance in Gerontopsychiatric Patients
GAP
1 other identifier
interventional
407
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2015
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2017
CompletedFebruary 28, 2018
February 1, 2018
2.5 years
January 5, 2015
February 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of frequency and severity of adverse events
Participants will be followed for the duration of hospital stay and the follow-up-visit, an expected average of 6 weeks
Secondary Outcomes (6)
Assessment of cognitive functioning
At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)
Quality of life
At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)
Adverse drug reactions
Continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge
Serum level of substances
1 day at occurrence of SAR
Electrocardiogram
At baseline visit, at occurrence of SAR and at the final visit (expected average of hospital stay: 4 weeks)
- +1 more secondary outcomes
Study Arms (1)
Psychiatric drugs
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age 65+ years old
- Inpatients treated at one of the geriatric psychiatry study sites.
- Signed consent form ( Patient and/or legally authorized custodian)
You may not qualify if:
- Patients that are incapable to give their informed consent and are not under legally authorized custodianship.
- Parallel participation in another clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Bezirkskrankenhaus Augsburg
Augsburg, Germany
Krankenhaus Hedwigshöhe
Berlin, Germany
Hannover Medical School
Hanover, 30625, Germany
Asklepios Fachklinikum Lübben
Lubin, Germany
Asklepios Fachklinikum Teupitz
Teupitz, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helge Frieling, Prof., MD
Hannover Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2015
First Posted
March 2, 2015
Study Start
January 1, 2015
Primary Completion
June 28, 2017
Study Completion
June 28, 2017
Last Updated
February 28, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share