A Phase 3 interventional study of Phenobarbital and Phenytoin in Dementia, Depression and Schizophrenia, sponsored by Hannover Medical School. Terminated at 5 sites in Germany. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Hannover Medical School · Phase 3, Interventional, and Treatment
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.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's enrollment of 407 is above the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Assessment of frequency and severity of adverse events
Time frame: Participants will be followed for the duration of hospital stay and the follow-up-visit, an expected average of 6 weeks
Assessment of cognitive functioning
Mini mental state examination, intensive care delirium checklist
Time frame: At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)
Quality of life
SF-8
Time frame: At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)
Adverse drug reactions
Dosage record and treatment emergent symptoms scale (DOTES), geriatric adverse event rating scale (GEARS)
Time frame: Continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge
Serum level of substances
Time frame: 1 day at occurrence of SAR
Electrocardiogram
Time frame: At baseline visit, at occurrence of SAR and at the final visit (expected average of hospital stay: 4 weeks)
Medication intake
Morisky medication adherence scale (MMAS) and chart review
Time frame: 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
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2015 to primary completion in Jun 2017, 29 months.
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This study is terminated, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Phenobarbital · Phenytoin · Carbamazepine · Oxcarbazepine · Valproic Acid · Lamotrigine · Topiramate · Gabapentin · Levetiracetam · Pregabalin · Lacosamide · Clonazepam · Biperiden · Fluphenazine · Perphenazine · Thioridazine · Haloperidol · Pipamperone · Sertindole · Ziprasidone · Flupenthixol · Clopenthixol · Pimozide · Clozapine · Olanzapine · Quetiapine · Sulpiride · Amisulpride · Risperidone · Aripiprazole · Paliperidone · Diazepam · Oxazepam · Lorazepam · Clobazam · Alprazolam · Hydroxyzine · Buspirone · Chloral Hydrate · Triazolam · Temazepam · Midazolam · Brotizolam · Zopiclone · Zolpidem · Zaleplon · Melatonin · Diphenhydramine · Promethazine · Imipramine · Clomipramine · Amitriptyline · Nortriptyline · Doxepin · Fluoxetine · Citalopram · Paroxetine · Sertraline · Fluvoxamine · Escitalopram · Tranylcypromine · Moclobemide · Mianserin · Trazodone · Mirtazapine · Bupropion · Venlafaxine · Reboxetine · Duloxetine · Agomelatine · Piracetam · Donepezil · Rivastigmine · Galantamine · Memantine · Acamprosate · Lithium