Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
407 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-01-31
Study Completion Date
2017-06-28
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Psychiatric drugs
Group Type
EXPERIMENTAL
Phenobarbital
Intervention Type
DRUG
Phenytoin
Intervention Type
DRUG
Carbamazepine
Intervention Type
DRUG
Oxcarbazepine
Intervention Type
DRUG
Valproic Acid
Intervention Type
DRUG
Lamotrigine
Intervention Type
DRUG
Topiramate
Intervention Type
DRUG
Gabapentin
Intervention Type
DRUG
Levetiracetam
Intervention Type
DRUG
Pregabalin
Intervention Type
DRUG
Lacosamide
Intervention Type
DRUG
Clonazepam
Intervention Type
DRUG
Biperiden
Intervention Type
DRUG
Levomepromazine
Intervention Type
DRUG
Fluphenazine
Intervention Type
DRUG
Perphenazine
Intervention Type
DRUG
Perazine
Intervention Type
DRUG
Thioridazine
Intervention Type
DRUG
Haloperidol
Intervention Type
DRUG
Melperone
Intervention Type
DRUG
Pipamperone
Intervention Type
DRUG
Bromperidol
Intervention Type
DRUG
Benperidol
Intervention Type
DRUG
Sertindole
Intervention Type
DRUG
Ziprasidone
Intervention Type
DRUG
Flupentixol
Intervention Type
DRUG
Chlorprothixene
Intervention Type
DRUG
Zuclopenthixol
Intervention Type
DRUG
Fluspirilene
Intervention Type
DRUG
Pimozide
Intervention Type
DRUG
Clozapine
Intervention Type
DRUG
Olanzapine
Intervention Type
DRUG
Quetiapine
Intervention Type
DRUG
Sulpiride
Intervention Type
DRUG
Tiapride
Intervention Type
DRUG
Amisulpride
Intervention Type
DRUG
Prothipendyl
Intervention Type
DRUG
Risperidone
Intervention Type
DRUG
Aripiprazole
Intervention Type
DRUG
Paliperidone
Intervention Type
DRUG
Diazepam
Intervention Type
DRUG
Oxazepam
Intervention Type
DRUG
Lorazepam
Intervention Type
DRUG
Bromazepam
Intervention Type
DRUG
Clobazam
Intervention Type
DRUG
Alprazolam
Intervention Type
DRUG
Hydroxyzine
Intervention Type
DRUG
Buspirone
Intervention Type
DRUG
Chloral Hydrate
Intervention Type
DRUG
Flurazepam
Intervention Type
DRUG
Nitrazepam
Intervention Type
DRUG
Triazolam
Intervention Type
DRUG
Lormetazepam
Intervention Type
DRUG
Temazepam
Intervention Type
DRUG
Midazolam
Intervention Type
DRUG
Brotizolam
Intervention Type
DRUG
Zopiclone
Intervention Type
DRUG
Zolpidem
Intervention Type
DRUG
Zaleplon
Intervention Type
DRUG
Melatonin
Intervention Type
DRUG
Clomethiazole
Intervention Type
DRUG
Diphenhydramine
Intervention Type
DRUG
Promethazine
Intervention Type
DRUG
Imipramine
Intervention Type
DRUG
Clomipramine
Intervention Type
DRUG
Opipramol
Intervention Type
DRUG
Trimipramine
Intervention Type
DRUG
Amitriptyline
Intervention Type
DRUG
Nortriptyline
Intervention Type
DRUG
Doxepin
Intervention Type
DRUG
Maprotiline
Intervention Type
DRUG
Amitriptyline oxide
Intervention Type
DRUG
Fluoxetine
Intervention Type
DRUG
Citalopram
Intervention Type
DRUG
Paroxetine
Intervention Type
DRUG
Sertraline
Intervention Type
DRUG
Fluvoxamine
Intervention Type
DRUG
Escitalopram
Intervention Type
DRUG
Tranylcypromine
Intervention Type
DRUG
Moclobemide
Intervention Type
DRUG
Mianserin
Intervention Type
DRUG
Trazodone
Intervention Type
DRUG
Mirtazapine
Intervention Type
DRUG
Bupropion
Intervention Type
DRUG
Venlafaxine
Intervention Type
DRUG
Reboxetine
Intervention Type
DRUG
Duloxetine
Intervention Type
DRUG
Agomelatine
Intervention Type
DRUG
Pyritinol
Intervention Type
DRUG
Piracetam
Intervention Type
DRUG
Donepezil
Intervention Type
DRUG
Rivastigmine
Intervention Type
DRUG
Galantamine
Intervention Type
DRUG
Memantine
Intervention Type
DRUG
Nicergoline
Intervention Type
DRUG
Acamprosate
Intervention Type
DRUG
Lithium
Intervention Type
DRUG
Interventions
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Phenobarbital
Intervention Type
DRUG
Phenytoin
Intervention Type
DRUG
Carbamazepine
Intervention Type
DRUG
Oxcarbazepine
Intervention Type
DRUG
Valproic Acid
Intervention Type
DRUG
Lamotrigine
Intervention Type
DRUG
Topiramate
Intervention Type
DRUG
Gabapentin
Intervention Type
DRUG
Levetiracetam
Intervention Type
DRUG
Pregabalin
Intervention Type
DRUG
Lacosamide
Intervention Type
DRUG
Clonazepam
Intervention Type
DRUG
Biperiden
Intervention Type
DRUG
Levomepromazine
Intervention Type
DRUG
Fluphenazine
Intervention Type
DRUG
Perphenazine
Intervention Type
DRUG
Perazine
Intervention Type
DRUG
Thioridazine
Intervention Type
DRUG
Haloperidol
Intervention Type
DRUG
Melperone
Intervention Type
DRUG
Pipamperone
Intervention Type
DRUG
Bromperidol
Intervention Type
DRUG
Benperidol
Intervention Type
DRUG
Sertindole
Intervention Type
DRUG
Ziprasidone
Intervention Type
DRUG
Flupentixol
Intervention Type
DRUG
Chlorprothixene
Intervention Type
DRUG
Zuclopenthixol
Intervention Type
DRUG
Fluspirilene
Intervention Type
DRUG
Pimozide
Intervention Type
DRUG
Clozapine
Intervention Type
DRUG
Olanzapine
Intervention Type
DRUG
Quetiapine
Intervention Type
DRUG
Sulpiride
Intervention Type
DRUG
Tiapride
Intervention Type
DRUG
Amisulpride
Intervention Type
DRUG
Prothipendyl
Intervention Type
DRUG
Risperidone
Intervention Type
DRUG
Aripiprazole
Intervention Type
DRUG
Paliperidone
Intervention Type
DRUG
Diazepam
Intervention Type
DRUG
Oxazepam
Intervention Type
DRUG
Lorazepam
Intervention Type
DRUG
Bromazepam
Intervention Type
DRUG
Clobazam
Intervention Type
DRUG
Alprazolam
Intervention Type
DRUG
Hydroxyzine
Intervention Type
DRUG
Buspirone
Intervention Type
DRUG
Chloral Hydrate
Intervention Type
DRUG
Flurazepam
Intervention Type
DRUG
Nitrazepam
Intervention Type
DRUG
Triazolam
Intervention Type
DRUG
Lormetazepam
Intervention Type
DRUG
Temazepam
Intervention Type
DRUG
Midazolam
Intervention Type
DRUG
Brotizolam
Intervention Type
DRUG
Zopiclone
Intervention Type
DRUG
Zolpidem
Intervention Type
DRUG
Zaleplon
Intervention Type
DRUG
Melatonin
Intervention Type
DRUG
Clomethiazole
Intervention Type
DRUG
Diphenhydramine
Intervention Type
DRUG
Promethazine
Intervention Type
DRUG
Imipramine
Intervention Type
DRUG
Clomipramine
Intervention Type
DRUG
Opipramol
Intervention Type
DRUG
Trimipramine
Intervention Type
DRUG
Amitriptyline
Intervention Type
DRUG
Nortriptyline
Intervention Type
DRUG
Doxepin
Intervention Type
DRUG
Maprotiline
Intervention Type
DRUG
Amitriptyline oxide
Intervention Type
DRUG
Fluoxetine
Intervention Type
DRUG
Citalopram
Intervention Type
DRUG
Paroxetine
Intervention Type
DRUG
Sertraline
Intervention Type
DRUG
Fluvoxamine
Intervention Type
DRUG
Escitalopram
Intervention Type
DRUG
Tranylcypromine
Intervention Type
DRUG
Moclobemide
Intervention Type
DRUG
Mianserin
Intervention Type
DRUG
Trazodone
Intervention Type
DRUG
Mirtazapine
Intervention Type
DRUG
Bupropion
Intervention Type
DRUG
Venlafaxine
Intervention Type
DRUG
Reboxetine
Intervention Type
DRUG
Duloxetine
Intervention Type
DRUG
Agomelatine
Intervention Type
DRUG
Pyritinol
Intervention Type
DRUG
Piracetam
Intervention Type
DRUG
Donepezil
Intervention Type
DRUG
Rivastigmine
Intervention Type
DRUG
Galantamine
Intervention Type
DRUG
Memantine
Intervention Type
DRUG
Nicergoline
Intervention Type
DRUG
Acamprosate
Intervention Type
DRUG
Lithium
Intervention Type
DRUG
Eligibility Criteria
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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)
* 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.
* Parallel participation in another clinical trial.
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Hannover Medical School
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Helge Frieling, Prof., MD
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Bezirkskrankenhaus Augsburg
Augsburg, , Germany
Site Status
Krankenhaus Hedwigshöhe
Berlin, , Germany
Site Status
Hannover Medical School
Hanover, , Germany
Site Status
Asklepios Fachklinikum Lübben
Lubin, , Germany
Site Status
Asklepios Fachklinikum Teupitz
Teupitz, , Germany
Site Status
Countries
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Germany
Other Identifiers
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GAP-2014
Identifier Type: -
Identifier Source: org_study_id
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