Pharmacovigilance in Gerontopsychiatric Patients (GAP)

Hannover Medical School (MHH)

Status and phase

Terminated

Phase 3

Conditions

Schizophrenia

Psychosomatic Disorders

Depression

Anxiety Disorders

Dementia

Treatments

Drug: Zuclopenthixol

Drug: Zopiclone

Drug: Buspirone

Drug: Fluvoxamine

Drug: Ziprasidone

Drug: Benperidol

Drug: Sulpiride

Drug: Fluspirilene

Drug: Valproic Acid

Drug: Lorazepam

Drug: Chloral Hydrate

Drug: Melperone

Drug: Flurazepam

Drug: Phenobarbital

Drug: Hydroxyzine

Drug: Bromazepam

Drug: Pipamperone

Drug: Donepezil

Drug: Bromperidol

Drug: Clonazepam

Drug: Zaleplon

Drug: Imipramine

Drug: Fluoxetine

Drug: Opipramol

Drug: Pyritinol

Drug: Diazepam

Drug: Nitrazepam

Drug: Reboxetine

Drug: Amitriptyline oxide

Drug: Lacosamide

Drug: Nicergoline

Drug: Sertindole

Drug: Paroxetine

Drug: Olanzapine

Drug: Triazolam

Drug: Melatonin

Drug: Chlorprothixene

Drug: Mirtazapine

Drug: Bupropion

Drug: Mianserin

Drug: Phenytoin

Drug: Risperidone

Drug: Tranylcypromine

Drug: Alprazolam

Drug: Nortriptyline

Drug: Clomethiazole

Drug: Trazodone

Drug: Amisulpride

Drug: Haloperidol

Drug: Perphenazine

Drug: Temazepam

Drug: Thioridazine

Drug: Quetiapine

Drug: Flupentixol

Drug: Levetiracetam

Drug: Lamotrigine

Drug: Levomepromazine

Drug: Citalopram

Drug: Diphenhydramine

Drug: Escitalopram

Drug: Perazine

Drug: Pimozide

Drug: Trimipramine

Drug: Rivastigmine

Drug: Doxepin

Drug: Oxcarbazepine

Drug: Brotizolam

Drug: Zolpidem

Drug: Amitriptyline

Drug: Prothipendyl

Drug: Topiramate

Drug: Gabapentin

Drug: Fluphenazine

Drug: Promethazine

Drug: Sertraline

Drug: Moclobemide

Drug: Pregabalin

Drug: Oxazepam

Drug: Lormetazepam

Drug: Clomipramine

Drug: Duloxetine

Drug: Galantamine

Drug: Paliperidone

Drug: Maprotiline

Drug: Clobazam

Drug: Aripiprazole

Drug: Lithium

Drug: Piracetam

Drug: Midazolam

Drug: Agomelatine

Drug: Memantine

Drug: Tiapride

Drug: Carbamazepine

Drug: Biperiden

Drug: Acamprosate

Drug: Venlafaxine

Drug: Clozapine

Study type

Interventional

Funder types

Other

Identifiers

NCT02374567

GAP-2014

Details and patient eligibility

About

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.

Enrollment

407 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

407 participants in 1 patient group

Psychiatric drugs

Experimental group

Treatment: