An observational study in Dementia, Depression and Schizophrenia, sponsored by Hannover Medical School. Status unknown at 5 sites in Germany. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2013-05-29.
Sponsored by Hannover Medical School · Observational
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.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 256 across 553 observational studies indexed under Dementia.
Browse Dementia studies →Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Mini Mental State Exam
Time frame: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).
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
Before hospitalisation and after discharge by interview, during the hospital stay by patients chart.
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).
The record gives a start of May 2013, a primary completion of May 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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