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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychiatric drugs | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenobarbital | Drug |
| ||
| Phenytoin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of cognitive functioning | Mini mental state examination, intensive care delirium checklist | At baseline visit and at the final visit (expected average of hospital stay: 4 weeks) |
| Quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helge Frieling, Prof., MD | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezirkskrankenhaus Augsburg | Augsburg | Germany | ||||
| Krankenhaus Hedwigshöhe |
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|
| 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 |
|
SF-8
| At baseline visit and at the final visit (expected average of hospital stay: 4 weeks) |
| Adverse drug reactions | Dosage record and treatment emergent symptoms scale (DOTES), geriatric adverse event rating scale (GEARS) | 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) |
| Medication intake | Morisky medication adherence scale (MMAS) and chart review | Patients medication intake 2 weeks before hospitalization, continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge |
| Berlin |
| Germany |
| Hannover Medical School | Hanover | 30625 | Germany |
| Asklepios Fachklinikum Lübben | Lubin | Germany |
| Asklepios Fachklinikum Teupitz | Teupitz | Germany |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D003863 | Depression |
| D012559 | Schizophrenia |
| D011602 | Psychophysiologic Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010634 | Phenobarbital |
| D010672 | Phenytoin |
| D002220 | Carbamazepine |
| D000078330 | Oxcarbazepine |
| D014635 | Valproic Acid |
| D000077213 | Lamotrigine |
| D000077236 | Topiramate |
| D000077206 | Gabapentin |
| D000077287 | Levetiracetam |
| D000069583 | Pregabalin |
| D000078334 | Lacosamide |
| D002998 | Clonazepam |
| D001712 | Biperiden |
| D008728 | Methotrimeprazine |
| D005476 | Fluphenazine |
| D010546 | Perphenazine |
| D010464 | Perazine |
| D013881 | Thioridazine |
| D006220 | Haloperidol |
| C008522 | metylperon |
| C005569 | pipamperone |
| C006820 | bromperidol |
| D001544 | Benperidol |
| C066304 | sertindole |
| C092292 | ziprasidone |
| D005475 | Flupenthixol |
| D002749 | Chlorprothixene |
| D003006 | Clopenthixol |
| D005484 | Fluspirilene |
| D010868 | Pimozide |
| D003024 | Clozapine |
| D000077152 | Olanzapine |
| D000069348 | Quetiapine Fumarate |
| D013469 | Sulpiride |
| D063325 | Tiapride Hydrochloride |
| D000077582 | Amisulpride |
| C069248 | prothipendyl |
| D018967 | Risperidone |
| D000068180 | Aripiprazole |
| D000068882 | Paliperidone Palmitate |
| D003975 | Diazepam |
| D010076 | Oxazepam |
| D008140 | Lorazepam |
| D001960 | Bromazepam |
| D000078306 | Clobazam |
| D000525 | Alprazolam |
| D006919 | Hydroxyzine |
| D002065 | Buspirone |
| D002697 | Chloral Hydrate |
| D005479 | Flurazepam |
| D009567 | Nitrazepam |
| D014229 | Triazolam |
| C023842 | lormetazepam |
| D013693 | Temazepam |
| D008874 | Midazolam |
| C020960 | brotizolam |
| C515050 | zopiclone |
| D000077334 | Zolpidem |
| C085665 | zaleplon |
| D008550 | Melatonin |
| D002719 | Chlormethiazole |
| D004155 | Diphenhydramine |
| D011398 | Promethazine |
| D007099 | Imipramine |
| D002997 | Clomipramine |
| D009888 | Opipramol |
| D014299 | Trimipramine |
| D000639 | Amitriptyline |
| D009661 | Nortriptyline |
| D004316 | Doxepin |
| D008376 | Maprotiline |
| C006566 | amitriptyline N-oxide |
| D005473 | Fluoxetine |
| D015283 | Citalopram |
| D017374 | Paroxetine |
| D020280 | Sertraline |
| D016666 | Fluvoxamine |
| D000089983 | Escitalopram |
| D014191 | Tranylcypromine |
| D020912 | Moclobemide |
| D008803 | Mianserin |
| D014196 | Trazodone |
| D000078785 | Mirtazapine |
| D016642 | Bupropion |
| D000069470 | Venlafaxine Hydrochloride |
| D000077593 | Reboxetine |
| D000068736 | Duloxetine Hydrochloride |
| C084711 | agomelatine |
| D011746 | Pyrithioxin |
| D010889 | Piracetam |
| D000077265 | Donepezil |
| D000068836 | Rivastigmine |
| D005702 | Galantamine |
| D008559 | Memantine |
| D009530 | Nicergoline |
| D000077443 | Acamprosate |
| D008094 | Lithium |
| ID | Term |
|---|---|
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D014227 | Triazines |
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000081 | Acetamides |
| D000577 | Amides |
| D000085 | Acetates |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D001643 | Bridged Bicyclo Compounds |
| D001952 | Bridged-Ring Compounds |
| D010880 | Piperidines |
| D053961 | Azabicyclo Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D013892 | Thioxanthenes |
| D010879 | Piperazines |
| D014966 | Xanthenes |
| D013141 | Spiro Compounds |
| D011083 | Polycyclic Compounds |
| D001562 | Benzimidazoles |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D001549 | Benzamides |
| D001565 | Benzoates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D005021 | Ethylamines |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D007555 | Isoxazoles |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D011725 | Pyridines |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013844 | Thiazoles |
| D001559 | Benzhydryl Compounds |
| D011437 | Propylamines |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D010082 | Oxepins |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D003990 | Dibenzoxepins |
| D000873 | Anthracenes |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D015057 | 1-Naphthylamine |
| D009281 | Naphthalenes |
| D010091 | Oximes |
| D006898 | Hydroxylamines |
| D002723 | Chlorobenzoates |
| D011728 | Pyridones |
| D011427 | Propiophenones |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D010627 | Phenethylamines |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D013876 | Thiophenes |
| D007189 | Indans |
| D007192 | Indenes |
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D000547 | Amantadine |
| D000218 | Adamantane |
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D013654 | Taurine |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
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