Pharmacovigilance in Gerontopsychiatric Patients

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

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

Sponsors & Collaborators

• Hannover Medical School

  lead OTHER

Principal Investigators

• Helge Frieling, Prof., MD · Hannover Medical School

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2017-06-28

Completion

2017-06-28

Countries

• Germany

Study Locations