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Pharmacovigilance in Gerontopsychiatric Patients

Information source: Hannover Medical School
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders

Intervention: 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 (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hannover Medical School

Official(s) and/or principal investigator(s):
Helge Frieling, Prof., MD, Principal Investigator, Affiliation: Hannover Medical School

Overall contact:
Alexandra Kleimann, Phone: +49 (0)511 532, Ext: 2403, Email: kleimann.alexandra@mh-hannover.de


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.

Clinical Details

Official title: Pharmacovigilance in Gerontopsychiatric Patients

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Assessment of frequency and severity of adverse events

Secondary outcome:

Assessment of cognitive functioning

Quality of life

Adverse drug reactions

Serum level of substances


Medication intake


Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Alexandra Kleimann, Phone: +49 (0)511 532, Ext: 2403, Email: kleimann.alexandra@mh-hannover.de

Bezirkskrankenhaus Augsburg, Augsburg, Germany; Recruiting
Susanne Stübner, PD, MD, Phone: +49 (0)821 4803 1021
Susanne Stübner, PD, MD, Principal Investigator

Krankenhaus Hedwigshöhe, Berlin, Germany; Recruiting
Vjera Holthoff-Detto, Prof., MD, Phone: +49 (0)30 67 41 30 01
Vjera Holthoff-Detto, Prof., MD, Principal Investigator

Hannover Medical School, Hannover 30625, Germany; Recruiting
Helge Frieling, Prof., MD, Phone: +49 (0)511 532, Ext: 6840, Email: Frieling.Helge@mh-hannover.de
Helge Frieling, Prof., MD, Principal Investigator

Asklepios Fachklinikum Lübben, Lübben, Germany; Recruiting
Stefan Kropp, Prof., MD, Phone: +49 (0) 3546 29200, Email: s.kropp@asklepios.com
Stefan Kropp, Prof., MD, Principal Investigator

Asklepios Fachklinikum Teupitz, Teupitz, Germany; Recruiting
Stefan Kropp, Prof., MD, Phone: +49 (0)33766 66276, Email: s.kropp@asklepios.com
Stefan Kropp, Prof., MD, Principal Investigator

Additional Information

Starting date: January 2015
Last updated: March 24, 2015

Page last updated: August 23, 2015

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