DementiaGAPNCT01858857
Geriatric Psychiatry and Pharmacovigilance
An observational study of Dementia and Depression, run by Hannover Medical School at 5 sites in Germany.
Trial summary
The purpose of this observational multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Depression, Schizophrenia
- How many people
- 4,000 participants
- Where
- 5 sitesGermany
- Study dates
- May 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 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.
Who may be able to join
- Age 65+ years old
- Inpatients treated at one of the geriatric psychiatry study sites.
- Signed consent form ( Patient and/or legally authorized custodian)
Who cannot join
- 1. Patients that are incapable to give their informed consent and are not under legally authorized custodianship.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
Krankenhaus Hedwigshöhe
Berlin
Beirich Susanne, s.beirich@alexius.de
Hans Gutzmann, MD
- Recruiting
Asklepios Fachklinikum Brandenburg
Brandenburg an der Havel
Felix Hohl-Radke, MD, +49 3381 782156
Felix Hohl-Radke, MD
- Recruiting
Hannover Medical School
Hanover, 30625
Petra Garlipp, MD, +495115326559, garlipp.petra@mh-hannover.de
Petra Garlipp, MD
- Recruiting
Asklepios Fachklinikum Lübben
Lubin
Kropp Stefan, MD, +49 3546 29200
Stefan Kropp, MD
- Recruiting
Asklepios Fachklinikum Teupitz
Teupitz
Stefan Kropp, +4933766660
Stefan Kropp, MD
About this study
Official title: Pharmacovigilance in Gerontopsychiatric Patients
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.
Read more
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.
- Conditions
- Dementia, Depression, Schizophrenia, Psychosomatic Disorders, Anxiety Disorders
- Keywords
- geriatric psychiatry, pharmacovigilance
- Medical subject headings
- Dementia, Depression, Schizophrenia, Psychophysiologic Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric psychiatric in patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of frequency and severity of adverse events in geriatric psychiatry inpatients under psychopharmacological treatment
Measured: 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 (6)
Assessment of cognitive functioning
Mini Mental State Exam
Measured: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).
Quality of life
Measured: At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).
Adverse drug reactions
Measured: 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
Measured: 1 day at occurence of SAE
Electrocardiogram
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Institut für Arzneimittelsicherheit in der Psychiatrie AMSP e.V., Asklepios Fachklinikum Brandenburg, Asklepios Fachklinikum Lübben für Psychiatrie, Psychotherapie und Psychosomatik, Asklepios Fachklinikum Teupitz für Psychiatrie, Krankenhaus Hedwigshöhe, Kompetenznetz TDM KJP e.V.
- Responsible party
- Principal investigator, Helge Frieling,MD, Hannover Medical School
- Investigators
- Helge Frieling, MD, Principal investigator, MHHSermin Toto, MD, Study director, MHHStefan Bleich, MD, Study chair, MHH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858857
- Sponsor's protocol ID
- GAP2013
- Other IDs
- V-15222/68605/2012-2015
- Acronym
- GAP
- Status last verified
- May 2013
- First submitted
- 15 May 2013
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacovigilance in Gerontopsychiatric Patients
- ClinicalTrials.gov ID
- NCT01858857
- Acronym / sponsor ID
- GAP / GAP2013
- Conditions
- Dementia, Depression, Schizophrenia, Psychosomatic Disorders, Anxiety Disorders
- Keywords
- geriatric psychiatry, pharmacovigilance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Institut für Arzneimittelsicherheit in der Psychiatrie AMSP e.V., Asklepios Fachklinikum Brandenburg, Asklepios Fachklinikum Lübben für Psychiatrie, Psychotherapie und Psychosomatik, Asklepios Fachklinikum Teupitz für Psychiatrie, Krankenhaus Hedwigshöhe, Kompetenznetz TDM KJP e.V.
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric psychiatric in patients | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Age 65+ years old
- Inpatients treated at one of the geriatric psychiatry study sites.
- Signed consent form ( Patient and/or legally authorized custodian)
Key exclusion criteria (1 listed)
- 1. Patients that are incapable to give their informed consent and are not under legally authorized custodianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helge Frieling, MD principal investigator
MHH
Sermin Toto, MD study director
MHH
Stefan Bleich, MD study chair
MHH
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Depression, run by Hannover Medical School at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Kleimann, MD (+495115326559, gap_study@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.