Pharmacovigilance in Gerontopsychiatric Patients
Information source: Hannover Medical School
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Intervention: Phenobarbital (Drug); Phenytoin (Drug); Carbamazepine (Drug); Oxcarbazepine (Drug); Valproic Acid (Drug); Lamotrigine (Drug); Topiramate (Drug); Gabapentin (Drug); Levetiracetam (Drug); Pregabalin (Drug); Lacosamide (Drug); Clonazepam (Drug); Biperiden (Drug); Levomepromazine (Drug); Fluphenazine (Drug); Perphenazine (Drug); Perazine (Drug); Thioridazine (Drug); Haloperidol (Drug); Melperone (Drug); Pipamperone (Drug); Bromperidol (Drug); Benperidol (Drug); Sertindole (Drug); Ziprasidone (Drug); Flupentixol (Drug); Chlorprothixene (Drug); Zuclopenthixol (Drug); Fluspirilene (Drug); Pimozide (Drug); Clozapine (Drug); Olanzapine (Drug); Quetiapine (Drug); Sulpiride (Drug); Tiapride (Drug); Amisulpride (Drug); Prothipendyl (Drug); Risperidone (Drug); Aripiprazole (Drug); Paliperidone (Drug); Diazepam (Drug); Oxazepam (Drug); Lorazepam (Drug); Bromazepam (Drug); Clobazam (Drug); Alprazolam (Drug); Hydroxyzine (Drug); Buspirone (Drug); Chloral Hydrate (Drug); Flurazepam (Drug); Nitrazepam (Drug); Triazolam (Drug); Lormetazepam (Drug); Temazepam (Drug); Midazolam (Drug); Brotizolam (Drug); Zopiclone (Drug); Zolpidem (Drug); Zaleplon (Drug); Melatonin (Drug); Clomethiazole (Drug); Diphenhydramine (Drug); Promethazine (Drug); Imipramine (Drug); Clomipramine (Drug); Opipramol (Drug); Trimipramine (Drug); Amitriptyline (Drug); Nortriptyline (Drug); Doxepin (Drug); Maprotiline (Drug); Amitriptyline oxide (Drug); Fluoxetine (Drug); Citalopram (Drug); Paroxetine (Drug); Sertraline (Drug); Fluvoxamine (Drug); Escitalopram (Drug); Tranylcypromine (Drug); Moclobemide (Drug); Mianserin (Drug); Trazodone (Drug); Mirtazapine (Drug); Bupropion (Drug); Venlafaxine (Drug); Reboxetine (Drug); Duloxetine (Drug); Agomelatine (Drug); Pyritinol (Drug); Piracetam (Drug); Donepezil (Drug); Rivastigmine (Drug); Galantamine (Drug); Memantine (Drug); Nicergoline (Drug); Acamprosate (Drug); Lithium (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hannover Medical School Official(s) and/or principal investigator(s): Helge Frieling, Prof., MD, Principal Investigator, Affiliation: Hannover Medical School
Overall contact: Alexandra Kleimann, Phone: +49 (0)511 532, Ext: 2403, Email: kleimann.alexandra@mh-hannover.de
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.
Clinical Details
Official title: Pharmacovigilance in Gerontopsychiatric Patients
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Assessment of frequency and severity of adverse events
Secondary outcome: Assessment of cognitive functioningQuality of life Adverse drug reactions Serum level of substances Electrocardiogram Medication intake
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 65+ years old
- Inpatients treated at one of the geriatric psychiatry study sites.
- Signed consent form ( Patient and/or legally authorized custodian)
Exclusion Criteria:
- Patients that are incapable to give their informed consent and are not under legally
authorized custodianship.
- Parallel participation in another clinical trial.
Locations and Contacts
Alexandra Kleimann, Phone: +49 (0)511 532, Ext: 2403, Email: kleimann.alexandra@mh-hannover.de
Bezirkskrankenhaus Augsburg, Augsburg, Germany; Recruiting Susanne Stübner, PD, MD, Phone: +49 (0)821 4803 1021 Susanne Stübner, PD, MD, Principal Investigator
Krankenhaus Hedwigshöhe, Berlin, Germany; Recruiting Vjera Holthoff-Detto, Prof., MD, Phone: +49 (0)30 67 41 30 01 Vjera Holthoff-Detto, Prof., MD, Principal Investigator
Hannover Medical School, Hannover 30625, Germany; Recruiting Helge Frieling, Prof., MD, Phone: +49 (0)511 532, Ext: 6840, Email: Frieling.Helge@mh-hannover.de Helge Frieling, Prof., MD, Principal Investigator
Asklepios Fachklinikum Lübben, Lübben, Germany; Recruiting Stefan Kropp, Prof., MD, Phone: +49 (0) 3546 29200, Email: s.kropp@asklepios.com Stefan Kropp, Prof., MD, Principal Investigator
Asklepios Fachklinikum Teupitz, Teupitz, Germany; Recruiting Stefan Kropp, Prof., MD, Phone: +49 (0)33766 66276, Email: s.kropp@asklepios.com Stefan Kropp, Prof., MD, Principal Investigator
Additional Information
Starting date: January 2015
Last updated: March 24, 2015
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