Pharmacovigilance in Gerontopsychiatric Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 407
- 试验地点
- 5
- 主要终点
- Assessment of frequency and severity of adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65+ years old
- •Inpatients treated at one of the geriatric psychiatry study sites.
- •Signed consent form ( Patient and/or legally authorized custodian)
排除标准
- •Patients that are incapable to give their informed consent and are not under legally authorized custodianship.
- •Parallel participation in another clinical trial.
研究组 & 干预措施
Psychiatric drugs
干预措施: Topiramate (Drug)
Psychiatric drugs
干预措施: Fluphenazine (Drug)
Psychiatric drugs
干预措施: Temazepam (Drug)
Psychiatric drugs
干预措施: Clomipramine (Drug)
Psychiatric drugs
干预措施: Lamotrigine (Drug)
Psychiatric drugs
干预措施: Phenobarbital (Drug)
Psychiatric drugs
干预措施: Phenytoin (Drug)
Psychiatric drugs
干预措施: Carbamazepine (Drug)
Psychiatric drugs
干预措施: Oxcarbazepine (Drug)
Psychiatric drugs
干预措施: Valproic Acid (Drug)
Psychiatric drugs
干预措施: Gabapentin (Drug)
Psychiatric drugs
干预措施: Levetiracetam (Drug)
Psychiatric drugs
干预措施: Pregabalin (Drug)
Psychiatric drugs
干预措施: Lacosamide (Drug)
Psychiatric drugs
干预措施: Clonazepam (Drug)
Psychiatric drugs
干预措施: Biperiden (Drug)
Psychiatric drugs
干预措施: Levomepromazine (Drug)
Psychiatric drugs
干预措施: Perphenazine (Drug)
Psychiatric drugs
干预措施: Perazine (Drug)
Psychiatric drugs
干预措施: Thioridazine (Drug)
Psychiatric drugs
干预措施: Lorazepam (Drug)
Psychiatric drugs
干预措施: Bromazepam (Drug)
Psychiatric drugs
干预措施: Haloperidol (Drug)
Psychiatric drugs
干预措施: Melperone (Drug)
Psychiatric drugs
干预措施: Pipamperone (Drug)
Psychiatric drugs
干预措施: Bromperidol (Drug)
Psychiatric drugs
干预措施: Clobazam (Drug)
Psychiatric drugs
干预措施: Benperidol (Drug)
Psychiatric drugs
干预措施: Sertindole (Drug)
Psychiatric drugs
干预措施: Ziprasidone (Drug)
Psychiatric drugs
干预措施: Flupentixol (Drug)
Psychiatric drugs
干预措施: Chlorprothixene (Drug)
Psychiatric drugs
干预措施: Zuclopenthixol (Drug)
Psychiatric drugs
干预措施: Fluspirilene (Drug)
Psychiatric drugs
干预措施: Pimozide (Drug)
Psychiatric drugs
干预措施: Clozapine (Drug)
Psychiatric drugs
干预措施: Olanzapine (Drug)
Psychiatric drugs
干预措施: Quetiapine (Drug)
Psychiatric drugs
干预措施: Sulpiride (Drug)
Psychiatric drugs
干预措施: Tiapride (Drug)
Psychiatric drugs
干预措施: Amisulpride (Drug)
Psychiatric drugs
干预措施: Prothipendyl (Drug)
Psychiatric drugs
干预措施: Alprazolam (Drug)
Psychiatric drugs
干预措施: Risperidone (Drug)
Psychiatric drugs
干预措施: Aripiprazole (Drug)
Psychiatric drugs
干预措施: Paliperidone (Drug)
Psychiatric drugs
干预措施: Diazepam (Drug)
Psychiatric drugs
干预措施: Oxazepam (Drug)
Psychiatric drugs
干预措施: Hydroxyzine (Drug)
Psychiatric drugs
干预措施: Buspirone (Drug)
Psychiatric drugs
干预措施: Chloral Hydrate (Drug)
Psychiatric drugs
干预措施: Flurazepam (Drug)
Psychiatric drugs
干预措施: Nitrazepam (Drug)
Psychiatric drugs
干预措施: Triazolam (Drug)
Psychiatric drugs
干预措施: Lormetazepam (Drug)
Psychiatric drugs
干预措施: Midazolam (Drug)
Psychiatric drugs
干预措施: Brotizolam (Drug)
Psychiatric drugs
干预措施: Zopiclone (Drug)
Psychiatric drugs
干预措施: Zolpidem (Drug)
Psychiatric drugs
干预措施: Zaleplon (Drug)
Psychiatric drugs
干预措施: Melatonin (Drug)
Psychiatric drugs
干预措施: Clomethiazole (Drug)
Psychiatric drugs
干预措施: Diphenhydramine (Drug)
Psychiatric drugs
干预措施: Promethazine (Drug)
Psychiatric drugs
干预措施: Imipramine (Drug)
Psychiatric drugs
干预措施: Opipramol (Drug)
Psychiatric drugs
干预措施: Trimipramine (Drug)
Psychiatric drugs
干预措施: Amitriptyline (Drug)
Psychiatric drugs
干预措施: Nortriptyline (Drug)
Psychiatric drugs
干预措施: Duloxetine (Drug)
Psychiatric drugs
干预措施: Agomelatine (Drug)
Psychiatric drugs
干预措施: Doxepin (Drug)
Psychiatric drugs
干预措施: Maprotiline (Drug)
Psychiatric drugs
干预措施: Amitriptyline oxide (Drug)
Psychiatric drugs
干预措施: Fluoxetine (Drug)
Psychiatric drugs
干预措施: Citalopram (Drug)
Psychiatric drugs
干预措施: Paroxetine (Drug)
Psychiatric drugs
干预措施: Sertraline (Drug)
Psychiatric drugs
干预措施: Fluvoxamine (Drug)
Psychiatric drugs
干预措施: Escitalopram (Drug)
Psychiatric drugs
干预措施: Tranylcypromine (Drug)
Psychiatric drugs
干预措施: Moclobemide (Drug)
Psychiatric drugs
干预措施: Mianserin (Drug)
Psychiatric drugs
干预措施: Trazodone (Drug)
Psychiatric drugs
干预措施: Mirtazapine (Drug)
Psychiatric drugs
干预措施: Bupropion (Drug)
Psychiatric drugs
干预措施: Venlafaxine (Drug)
Psychiatric drugs
干预措施: Reboxetine (Drug)
Psychiatric drugs
干预措施: Pyritinol (Drug)
Psychiatric drugs
干预措施: Piracetam (Drug)
Psychiatric drugs
干预措施: Donepezil (Drug)
Psychiatric drugs
干预措施: Rivastigmine (Drug)
Psychiatric drugs
干预措施: Galantamine (Drug)
Psychiatric drugs
干预措施: Memantine (Drug)
Psychiatric drugs
干预措施: Nicergoline (Drug)
Psychiatric drugs
干预措施: Acamprosate (Drug)
Psychiatric drugs
干预措施: Lithium (Drug)
结局指标
主要结局
Assessment of frequency and severity of adverse events
时间窗: Participants will be followed for the duration of hospital stay and the follow-up-visit, an expected average of 6 weeks
次要结局
- Assessment of cognitive functioning(At baseline visit and at the final visit (expected average of hospital stay: 4 weeks))
- Quality of life(At baseline visit and at the final visit (expected average of hospital stay: 4 weeks))
- Adverse drug reactions(Continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge)
- 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)