Pharmacovigilance in Gerontopsychiatric Patients
Pharmacovigilance in Gerontopsychiatric Patients
Sponsors |
Lead Sponsor: Hannover Medical School |
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Source | 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. 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. |
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Overall Status | Terminated | ||||||||||||||
Start Date | January 2015 | ||||||||||||||
Completion Date | June 28, 2017 | ||||||||||||||
Primary Completion Date | June 28, 2017 | ||||||||||||||
Phase | Phase 3 | ||||||||||||||
Study Type | Interventional | ||||||||||||||
Primary Outcome |
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Secondary Outcome |
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Enrollment | 407 | ||||||||||||||
Condition | |||||||||||||||
Intervention |
Intervention Type: Drug Intervention Name: Phenobarbital Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Phenytoin Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Carbamazepine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Oxcarbazepine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Valproic Acid Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Lamotrigine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Topiramate Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Gabapentin Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Levetiracetam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Pregabalin Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Lacosamide Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Clonazepam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Biperiden Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Levomepromazine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Fluphenazine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Perphenazine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Perazine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Thioridazine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Haloperidol Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Melperone Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Pipamperone Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Bromperidol Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Benperidol Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Sertindole Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Ziprasidone Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Flupentixol Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Chlorprothixene Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Zuclopenthixol Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Fluspirilene Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Pimozide Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Clozapine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Olanzapine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Quetiapine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Sulpiride Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Tiapride Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Amisulpride Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Prothipendyl Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Risperidone Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Aripiprazole Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Paliperidone Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Diazepam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Oxazepam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Lorazepam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Bromazepam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Clobazam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Alprazolam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Hydroxyzine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Buspirone Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Chloral Hydrate Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Flurazepam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Nitrazepam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Triazolam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Lormetazepam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Temazepam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Midazolam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Brotizolam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Zopiclone Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Zolpidem Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Zaleplon Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Melatonin Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Clomethiazole Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Diphenhydramine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Promethazine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Imipramine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Clomipramine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Opipramol Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Trimipramine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Amitriptyline Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Nortriptyline Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Doxepin Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Maprotiline Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Amitriptyline oxide Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Fluoxetine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Citalopram Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Paroxetine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Sertraline Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Fluvoxamine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Escitalopram Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Tranylcypromine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Moclobemide Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Mianserin Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Trazodone Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Mirtazapine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Bupropion Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Venlafaxine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Reboxetine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Duloxetine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Agomelatine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Pyritinol Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Piracetam Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Donepezil Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Rivastigmine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Galantamine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Memantine Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Nicergoline Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Acamprosate Arm Group Label: Psychiatric drugs Intervention Type: Drug Intervention Name: Lithium Arm Group Label: Psychiatric drugs |
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Eligibility |
Criteria:
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. Gender: All Minimum Age: 65 Years Maximum Age: N/A Healthy Volunteers: No |
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Overall Official |
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Location |
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Location Countries |
Germany |
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Verification Date |
February 2018 |
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Responsible Party |
Type: Sponsor |
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Keywords | |||||||||||||||
Has Expanded Access | No | ||||||||||||||
Condition Browse | |||||||||||||||
Number Of Arms | 1 | ||||||||||||||
Arm Group |
Label: Psychiatric drugs Type: Experimental |
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Acronym | GAP | ||||||||||||||
Patient Data | No | ||||||||||||||
Study Design Info |
Allocation: N/A Intervention Model: Single Group Assignment Primary Purpose: Treatment Masking: None (Open Label) |