Pharmacovigilance in Gerontopsychiatric Patients

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacovigilance in Gerontopsychiatric Patients

Conditions
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Dementia, Depression, Schizophrenia, Psychosomatic Disorders, Anxiety Disorders

Intervention / Treatment
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* Drug: 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychiatric drugs<br> | Drug: Phenobarbital<br> <br> Drug: Phenytoin<br> <br> Drug: Carbamazepine<br> <br> Drug: Oxcarbazepine<br> <br> Drug: Valproic Acid<br> <br> Drug: Lamotrigine<br> <br> Drug: Topiramate<br> <br> Drug: Gabapentin<br> <br> Drug: Levetiracetam<br> <br> Drug: Pregabalin<br> <br> Drug: Lacosamide<br> <br> Drug: Clonazepam<br> <br> Drug: Biperiden<br> <br> Drug: Levomepromazine<br> <br> Drug: Fluphenazine<br> <br> Drug: Perphenazine<br> <br> Drug: Perazine<br> <br> Drug: Thioridazine<br> <br> Drug: Haloperidol<br> <br> Drug: Melperone<br> <br> Drug: Pipamperone<br> <br> Drug: Bromperidol<br> <br> Drug: Benperidol<br> <br> Drug: Sertindole<br> <br> Drug: Ziprasidone<br> <br> Drug: Flupentixol<br> <br> Drug: Chlorprothixene<br> <br> Drug: Zuclopenthixol<br> <br> Drug: Fluspirilene<br> <br> Drug: Pimozide<br> <br> Drug: Clozapine<br> <br> Drug: Olanzapine<br> <br> Drug: Quetiapine<br> <br> Drug: Sulpiride<br> <br> Drug: Tiapride<br> <br> Drug: Amisulpride<br> <br> Drug: Prothipendyl<br> <br> Drug: Risperidone<br> <br> Drug: Aripiprazole<br> <br> Drug: Paliperidone<br> <br> Drug: Diazepam<br> <br> Drug: Oxazepam<br> <br> Drug: Lorazepam<br> <br> Drug: Bromazepam<br> <br> Drug: Clobazam<br> <br> Drug: Alprazolam<br> <br> Drug: Hydroxyzine<br> <br> Drug: Buspirone<br> <br> Drug: Chloral Hydrate<br> <br> Drug: Flurazepam<br> <br> Drug: Nitrazepam<br> <br> Drug: Triazolam<br> <br> Drug: Lormetazepam<br> <br> Drug: Temazepam<br> <br> Drug: Midazolam<br> <br> Drug: Brotizolam<br> <br> Drug: Zopiclone<br> <br> Drug: Zolpidem<br> <br> Drug: Zaleplon<br> <br> Drug: Melatonin<br> <br> Drug: Clomethiazole<br> <br> Drug: Diphenhydramine<br> <br> Drug: Promethazine<br> <br> Drug: Imipramine<br> <br> Drug: Clomipramine<br> <br> Drug: Opipramol<br> <br> Drug: Trimipramine<br> <br> Drug: Amitriptyline<br> <br> Drug: Nortriptyline<br> <br> Drug: Doxepin<br> <br> Drug: Maprotiline<br> <br> Drug: Amitriptyline oxide<br> <br> Drug: Fluoxetine<br> <br> Drug: Citalopram<br> <br> Drug: Paroxetine<br> <br> Drug: Sertraline<br> <br> Drug: Fluvoxamine<br> <br> Drug: Escitalopram<br> <br> Drug: Tranylcypromine<br> <br> Drug: Moclobemide<br> <br> Drug: Mianserin<br> <br> Drug: Trazodone<br> <br> Drug: Mirtazapine<br> <br> Drug: Bupropion<br> <br> Drug: Venlafaxine<br> <br> Drug: Reboxetine<br> <br> Drug: Duloxetine<br> <br> Drug: Agomelatine<br> <br> Drug: Pyritinol<br> <br> Drug: Piracetam<br> <br> Drug: Donepezil<br> <br> Drug: Rivastigmine<br> <br> Drug: Galantamine<br> <br> Drug: Memantine<br> <br> Drug: Nicergoline<br> <br> Drug: Acamprosate<br> <br> Drug: Lithium<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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geriatric psychiatry, pharmacovigilance