Pharmacovigilance in Gerontopsychiatric Patients
- Conditions
- DementiaDepressionSchizophreniaPsychosomatic DisordersAnxiety Disorders
- Interventions
- Registration Number
- NCT02374567
- Lead Sponsor
- Hannover Medical School
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 407
- Age 65+ years old
- Inpatients treated at one of the geriatric psychiatry study sites.
- Signed consent form ( Patient and/or legally authorized custodian)
- Patients that are incapable to give their informed consent and are not under legally authorized custodianship.
- Parallel participation in another clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Psychiatric drugs Phenytoin - Psychiatric drugs Carbamazepine - Psychiatric drugs Oxcarbazepine - Psychiatric drugs Phenobarbital - Psychiatric drugs Amisulpride - Psychiatric drugs Fluphenazine - Psychiatric drugs Perphenazine - Psychiatric drugs Perazine - Psychiatric drugs Haloperidol - Psychiatric drugs Flupentixol - Psychiatric drugs Chlorprothixene - Psychiatric drugs Imipramine - Psychiatric drugs Clomipramine - Psychiatric drugs Opipramol - Psychiatric drugs Risperidone - Psychiatric drugs Aripiprazole - Psychiatric drugs Diazepam - Psychiatric drugs Oxazepam - Psychiatric drugs Lorazepam - Psychiatric drugs Bromazepam - Psychiatric drugs Clobazam - Psychiatric drugs Alprazolam - Psychiatric drugs Flurazepam - Psychiatric drugs Nitrazepam - Psychiatric drugs Triazolam - Psychiatric drugs Lormetazepam - Psychiatric drugs Temazepam - Psychiatric drugs Midazolam - Psychiatric drugs Brotizolam - Psychiatric drugs Zopiclone - Psychiatric drugs Zolpidem - Psychiatric drugs Zaleplon - Psychiatric drugs Melatonin - Psychiatric drugs Diphenhydramine - Psychiatric drugs Trimipramine - Psychiatric drugs Amitriptyline - Psychiatric drugs Amitriptyline oxide - Psychiatric drugs Fluoxetine - Psychiatric drugs Paroxetine - Psychiatric drugs Sertraline - Psychiatric drugs Tranylcypromine - Psychiatric drugs Trazodone - Psychiatric drugs Lithium - Psychiatric drugs Pyritinol - Psychiatric drugs Piracetam - Psychiatric drugs Donepezil - Psychiatric drugs Prothipendyl - Psychiatric drugs Moclobemide - Psychiatric drugs Mianserin - Psychiatric drugs Lamotrigine - Psychiatric drugs Hydroxyzine - Psychiatric drugs Sulpiride - Psychiatric drugs Olanzapine - Psychiatric drugs Fluvoxamine - Psychiatric drugs Valproic Acid - Psychiatric drugs Topiramate - Psychiatric drugs Levetiracetam - Psychiatric drugs Gabapentin - Psychiatric drugs Thioridazine - Psychiatric drugs Pregabalin - Psychiatric drugs Lacosamide - Psychiatric drugs Biperiden - Psychiatric drugs Clonazepam - Psychiatric drugs Levomepromazine - Psychiatric drugs Melperone - Psychiatric drugs Pipamperone - Psychiatric drugs Bromperidol - Psychiatric drugs Benperidol - Psychiatric drugs Sertindole - Psychiatric drugs Zuclopenthixol - Psychiatric drugs Ziprasidone - Psychiatric drugs Pimozide - Psychiatric drugs Clozapine - Psychiatric drugs Fluspirilene - Psychiatric drugs Quetiapine - Psychiatric drugs Tiapride - Psychiatric drugs Paliperidone - Psychiatric drugs Chloral Hydrate - Psychiatric drugs Buspirone - Psychiatric drugs Clomethiazole - Psychiatric drugs Promethazine - Psychiatric drugs Nortriptyline - Psychiatric drugs Maprotiline - Psychiatric drugs Doxepin - Psychiatric drugs Citalopram - Psychiatric drugs Escitalopram - Psychiatric drugs Mirtazapine - Psychiatric drugs Rivastigmine - Psychiatric drugs Bupropion - Psychiatric drugs Reboxetine - Psychiatric drugs Venlafaxine - Psychiatric drugs Duloxetine - Psychiatric drugs Agomelatine - Psychiatric drugs Galantamine - Psychiatric drugs Memantine - Psychiatric drugs Acamprosate - Psychiatric drugs Nicergoline -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Assessment of cognitive functioning At baseline visit and at the final visit (expected average of hospital stay: 4 weeks) Mini mental state examination, intensive care delirium checklist
Quality of life At baseline visit and at the final visit (expected average of hospital stay: 4 weeks) SF-8
Adverse drug reactions Continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge Dosage record and treatment emergent symptoms scale (DOTES), geriatric adverse event rating scale (GEARS)
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 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 Morisky medication adherence scale (MMAS) and chart review
Trial Locations
- Locations (5)
Bezirkskrankenhaus Augsburg
🇩🇪Augsburg, Germany
Krankenhaus Hedwigshöhe
🇩🇪Berlin, Germany
Hannover Medical School
🇩🇪Hannover, Germany
Asklepios Fachklinikum Teupitz
🇩🇪Teupitz, Germany
Asklepios Fachklinikum Lübben
🇩🇪Lübben, Germany