Geriatric Psychiatry and Pharmacovigilance (GAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01858857|
Recruitment Status : Unknown
Verified May 2013 by Helge Frieling,MD, Hannover Medical School.
Recruitment status was: Recruiting
First Posted : May 21, 2013
Last Update Posted : May 29, 2013
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.
|Condition or disease|
|Dementia Depression Schizophrenia Psychosomatic Disorders Anxiety Disorders|
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|Official Title:||Pharmacovigilance in Gerontopsychiatric Patients|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||December 2015|
|Geriatric psychiatric in 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858857
|Contact: Alexandra Kleimann, MDfirstname.lastname@example.org|
|Contact: Beirich Susanne email@example.com|
|Principal Investigator: Hans Gutzmann, MD|
|Asklepios Fachklinikum Brandenburg||Recruiting|
|Brandenburg an der Havel, Germany|
|Contact: Felix Hohl-Radke, MD +49 3381 782156|
|Principal Investigator: Felix Hohl-Radke, MD|
|Hannover Medical School||Recruiting|
|Hannover, Germany, 30625|
|Contact: Petra Garlipp, MD +495115326559 firstname.lastname@example.org|
|Principal Investigator: Petra Garlipp, MD|
|Asklepios Fachklinikum Lübben||Recruiting|
|Contact: Kropp Stefan, MD +49 3546 29200|
|Principal Investigator: Stefan Kropp, MD|
|Asklepios Fachklinikum Teupitz||Recruiting|
|Contact: Stefan Kropp +4933766660|
|Principal Investigator: Stefan Kropp, MD|
|Principal Investigator:||Helge Frieling, MD||MHH|
|Study Director:||Sermin Toto, MD||MHH|
|Study Chair:||Stefan Bleich, MD||MHH|