NCT02374567

Pharmacovigilance in Gerontopsychiatric Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia
• Depression
• Schizophrenia
• Psychosomatic Disorders
• Anxiety Disorders

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-06-28
• Completion: 2017-06-28
• First posted: 2015-03-02
• Last updated: 2018-02-28

Locations

5 sites across 1 country: Germany