Pharmacovigilance in Gerontopsychiatric Patients

Depression Clinical Trial

— GAP  

Official title:

Pharmacovigilance in Gerontopsychiatric Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02374567
• Other study ID #: GAP-2014
• Status: Terminated
• Phase: Phase 3
• First received: January 5, 2015
• Last updated: February 27, 2018
• Start date: January 2015
• Est. completion date: June 28, 2017

Study information

• Verified date: February 2018
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 407
• Est. completion date: June 28, 2017
• Est. primary completion date: June 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Dementia
• Depression
• Disease
• Psychophysiologic Disorders
• Psychosomatic Disorders
• Schizophrenia

Intervention

Drug:
• Phenobarbital

• Phenytoin

• Carbamazepine

• Oxcarbazepine

• Valproic Acid

• Lamotrigine

• Topiramate

• Gabapentin

• Levetiracetam

• Pregabalin

• Lacosamide

• Clonazepam

• Biperiden

• Levomepromazine

• Fluphenazine

• Perphenazine

• Perazine

• Thioridazine

• Haloperidol

• Melperone

• Pipamperone

• Bromperidol

• Benperidol

• Sertindole

• Ziprasidone

• Flupentixol

• Chlorprothixene

• Zuclopenthixol

• Fluspirilene

• Pimozide

• Clozapine

• Olanzapine

• Quetiapine

• Sulpiride

• Tiapride

• Amisulpride

• Prothipendyl

• Risperidone

• Aripiprazole

• Paliperidone

• Diazepam

• Oxazepam

• Lorazepam

• Bromazepam

• Clobazam

• Alprazolam

• Hydroxyzine

• Buspirone

• Chloral Hydrate

• Flurazepam

• Nitrazepam

• Triazolam

• Lormetazepam

• Temazepam

• Midazolam

• Brotizolam

• Zopiclone

• Zolpidem

• Zaleplon

• Melatonin

• Clomethiazole

• Diphenhydramine

• Promethazine

• Imipramine

• Clomipramine

• Opipramol

• Trimipramine

• Amitriptyline

• Nortriptyline

• Doxepin

• Maprotiline

• Amitriptyline oxide

• Fluoxetine

• Citalopram

• Paroxetine

• Sertraline

• Fluvoxamine

• Escitalopram

• Tranylcypromine

• Moclobemide

• Mianserin

• Trazodone

• Mirtazapine

• Bupropion

• Venlafaxine

• Reboxetine

• Duloxetine

• Agomelatine

• Pyritinol

• Piracetam

• Donepezil

• Rivastigmine

• Galantamine

• Memantine

• Nicergoline

• Acamprosate

• Lithium

Locations

Country	Name	City	State
Germany	Bezirkskrankenhaus Augsburg	Augsburg
Germany	Krankenhaus Hedwigshöhe	Berlin
Germany	Hannover Medical School	Hannover
Germany	Asklepios Fachklinikum Lübben	Lübben
Germany	Asklepios Fachklinikum Teupitz	Teupitz

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of frequency and severity of adverse events		Participants will be followed for the duration of hospital stay and the follow-up-visit, an expected average of 6 weeks
Secondary	Assessment of cognitive functioning	Mini mental state examination, intensive care delirium checklist	At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)
Secondary	Quality of life	SF-8	At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)
Secondary	Adverse drug reactions	Dosage record and treatment emergent symptoms scale (DOTES), geriatric adverse event rating scale (GEARS)	Continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge
Secondary	Serum level of substances		1 day at occurrence of SAR
Secondary	Electrocardiogram		At baseline visit, at occurrence of SAR and at the final visit (expected average of hospital stay: 4 weeks)
Secondary	Medication intake	Morisky medication adherence scale (MMAS) and chart review	Patients medication intake 2 weeks before hospitalization, continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge