GAP: Pharmacovigilance in Gerontopsychiatric Patients

Sponsor

Hannover Medical School (Other)

Overall Status

Terminated

CT.gov ID

NCT02374567

Collaborator

(none)

407

Enrollment

Locations

Arm

29.9

Actual Duration (Months)

81.4

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Depression Schizophrenia Psychosomatic Disorders Anxiety Disorders	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	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

407 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pharmacovigilance in Gerontopsychiatric Patients

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Jun 28, 2017

Actual Study Completion Date :

Jun 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Psychiatric drugs	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

Arm

Intervention/Treatment

Experimental: Psychiatric drugs

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Assessment of cognitive functioning [At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)]
Mini mental state examination, intensive care delirium checklist
Quality of life [At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)]
SF-8
Adverse drug reactions [Continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge]
Dosage record and treatment emergent symptoms scale (DOTES), geriatric adverse event rating scale (GEARS)
Serum level of substances [1 day at occurrence of SAR]
Electrocardiogram [At baseline visit, at occurrence of SAR and at the final visit (expected average of hospital stay: 4 weeks)]
Medication intake [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]
Morisky medication adherence scale (MMAS) and chart review

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Bezirkskrankenhaus Augsburg	Augsburg	Germany
2	Krankenhaus Hedwigshöhe	Berlin	Germany
3	Hannover Medical School	Hannover	Germany	30625
4	Asklepios Fachklinikum Lübben	Lübben	Germany
5	Asklepios Fachklinikum Teupitz	Teupitz	Germany