Pharmacovigilance in Gerontopsychiatric Patients

Phase 3

Terminated

• Conditions: Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
• Interventions: 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

• Registration Number: NCT02374567
• Lead Sponsor: Hannover Medical School

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. Furthermor...

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Primary Completion: 2017-06-28
• Study Completion: 2017-06-28
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 407

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)

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Exclusion Criteria

• Patients that are incapable to give their informed consent and are not under legally authorized custodianship.
• Parallel participation in another clinical trial.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psychiatric drugs	Phenytoin	-
Psychiatric drugs	Carbamazepine	-
Psychiatric drugs	Oxcarbazepine	-
Psychiatric drugs	Phenobarbital	-
Psychiatric drugs	Amisulpride	-
Psychiatric drugs	Fluphenazine	-
Psychiatric drugs	Perphenazine	-
Psychiatric drugs	Perazine	-
Psychiatric drugs	Haloperidol	-
Psychiatric drugs	Flupentixol	-
Psychiatric drugs	Chlorprothixene	-
Psychiatric drugs	Imipramine	-
Psychiatric drugs	Clomipramine	-
Psychiatric drugs	Opipramol	-
Psychiatric drugs	Risperidone	-
Psychiatric drugs	Aripiprazole	-
Psychiatric drugs	Diazepam	-
Psychiatric drugs	Oxazepam	-
Psychiatric drugs	Lorazepam	-
Psychiatric drugs	Bromazepam	-
Psychiatric drugs	Clobazam	-
Psychiatric drugs	Alprazolam	-
Psychiatric drugs	Flurazepam	-
Psychiatric drugs	Nitrazepam	-
Psychiatric drugs	Triazolam	-
Psychiatric drugs	Lormetazepam	-
Psychiatric drugs	Temazepam	-
Psychiatric drugs	Midazolam	-
Psychiatric drugs	Brotizolam	-
Psychiatric drugs	Zopiclone	-
Psychiatric drugs	Zolpidem	-
Psychiatric drugs	Zaleplon	-
Psychiatric drugs	Melatonin	-
Psychiatric drugs	Diphenhydramine	-
Psychiatric drugs	Trimipramine	-
Psychiatric drugs	Amitriptyline	-
Psychiatric drugs	Amitriptyline oxide	-
Psychiatric drugs	Fluoxetine	-
Psychiatric drugs	Paroxetine	-
Psychiatric drugs	Sertraline	-
Psychiatric drugs	Tranylcypromine	-
Psychiatric drugs	Trazodone	-
Psychiatric drugs	Lithium	-
Psychiatric drugs	Pyritinol	-
Psychiatric drugs	Piracetam	-
Psychiatric drugs	Donepezil	-
Psychiatric drugs	Prothipendyl	-
Psychiatric drugs	Moclobemide	-
Psychiatric drugs	Mianserin	-
Psychiatric drugs	Lamotrigine	-
Psychiatric drugs	Hydroxyzine	-
Psychiatric drugs	Sulpiride	-
Psychiatric drugs	Olanzapine	-
Psychiatric drugs	Fluvoxamine	-
Psychiatric drugs	Valproic Acid	-
Psychiatric drugs	Topiramate	-
Psychiatric drugs	Levetiracetam	-
Psychiatric drugs	Gabapentin	-
Psychiatric drugs	Thioridazine	-
Psychiatric drugs	Pregabalin	-
Psychiatric drugs	Lacosamide	-
Psychiatric drugs	Biperiden	-
Psychiatric drugs	Clonazepam	-
Psychiatric drugs	Levomepromazine	-
Psychiatric drugs	Melperone	-
Psychiatric drugs	Pipamperone	-
Psychiatric drugs	Bromperidol	-
Psychiatric drugs	Benperidol	-
Psychiatric drugs	Sertindole	-
Psychiatric drugs	Zuclopenthixol	-
Psychiatric drugs	Ziprasidone	-
Psychiatric drugs	Pimozide	-
Psychiatric drugs	Clozapine	-
Psychiatric drugs	Fluspirilene	-
Psychiatric drugs	Quetiapine	-
Psychiatric drugs	Tiapride	-
Psychiatric drugs	Paliperidone	-
Psychiatric drugs	Chloral Hydrate	-
Psychiatric drugs	Buspirone	-
Psychiatric drugs	Clomethiazole	-
Psychiatric drugs	Promethazine	-
Psychiatric drugs	Nortriptyline	-
Psychiatric drugs	Maprotiline	-
Psychiatric drugs	Doxepin	-
Psychiatric drugs	Citalopram	-
Psychiatric drugs	Escitalopram	-
Psychiatric drugs	Mirtazapine	-
Psychiatric drugs	Rivastigmine	-
Psychiatric drugs	Bupropion	-
Psychiatric drugs	Reboxetine	-
Psychiatric drugs	Venlafaxine	-
Psychiatric drugs	Duloxetine	-
Psychiatric drugs	Agomelatine	-
Psychiatric drugs	Galantamine	-
Psychiatric drugs	Memantine	-
Psychiatric drugs	Acamprosate	-
Psychiatric drugs	Nicergoline	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Bezirkskrankenhaus Augsburg; 🇩🇪 Augsburg, Germany

Krankenhaus Hedwigshöhe; 🇩🇪 Berlin, Germany

Hannover Medical School; 🇩🇪 Hannover, Germany

Asklepios Fachklinikum Teupitz; 🇩🇪 Teupitz, Germany

Asklepios Fachklinikum Lübben; 🇩🇪 Lübben, Germany