Pharmacovigilance in Gerontopsychiatric Patients

• Status: Terminated
• Trial end date: 2017-06-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hannover Medical School
• Treatments: Acamprosate; Alprazolam; Amisulpride; Amitriptyline; Amitriptyline, perphenazine drug combination; Aripiprazole; Benperidol; Biperiden; Bromazepam; Bromperidol; Brotizolam; Bupropion; Buspirone; Carbamazepine; Chloral Hydrate; Chlormethiazole; Chlorprothixene; Citalopram; Clobazam; Clomethiazole edisylate; Clomipramine; Clonazepam; Clopenthixol; Clozapine; Diazepam; Diphenhydramine; Donepezil; Doxepin; Duloxetine Hydrochloride; Etiracetam; Fluoxetine; Flupenthixol; Flupenthixol decanoate; Fluphenazine; Fluphenazine depot; Fluphenazine enanthate; Flurazepam; Fluspirilene; Fluvoxamine; Gabapentin; Galantamine; Haloperidol; Hydroxyzine; Imipramine; Lacosamide; Lamotrigine; Levetiracetam; Lorazepam; Lormetazepam; Maprotiline; Melatonin; Memantine; Methotrimeprazine; Mianserin; Midazolam; Mirtazapine; Moclobemide; Nicergoline; Nitrazepam; Nortriptyline; Olanzapine; Opipramol; Oxazepam; Oxcarbazepine; Paliperidone Palmitate; Paroxetine; Perazine; Perphenazine; Phenobarbital; Phenytoin; Pimozide; Pipamperone; Piracetam; Pregabalin; Promethazine; Quetiapine Fumarate; Reboxetine; Risperidone; Rivastigmine; S 20098; Sertindole; Sertraline; Sulpiride; Sultopride; Temazepam; Thioridazine; Tiapride Hydrochloride; Topiramate; Tranylcypromine; Trazodone; Triazolam; Trimipramine; Valproic Acid; Venlafaxine Hydrochloride; Zaleplon; Ziprasidone; Zolpidem; Zopiclone

Criteria

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.