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Pharmacovigilance in Gerontopsychiatric Patients (GAP)

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ClinicalTrials.gov Identifier: NCT02374567
Recruitment Status : Terminated
First Posted : March 2, 2015
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Dementia Depression Schizophrenia Psychosomatic Disorders Anxiety Disorders 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 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacovigilance in Gerontopsychiatric Patients
Actual Study Start Date : January 2015
Actual Primary Completion Date : June 28, 2017
Actual Study Completion Date : June 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psychiatric drugs 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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assessment of cognitive functioning [ Time Frame: At baseline visit and at the final visit (expected average of hospital stay: 4 weeks) ]
    Mini mental state examination, intensive care delirium checklist

  2. Quality of life [ Time Frame: At baseline visit and at the final visit (expected average of hospital stay: 4 weeks) ]
    SF-8

  3. Adverse drug reactions [ Time Frame: 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)

  4. Serum level of substances [ Time Frame: 1 day at occurrence of SAR ]
  5. Electrocardiogram [ Time Frame: At baseline visit, at occurrence of SAR and at the final visit (expected average of hospital stay: 4 weeks) ]
  6. Medication intake [ 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 ]
    Morisky medication adherence scale (MMAS) and chart review



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374567


Locations
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Germany
Bezirkskrankenhaus Augsburg
Augsburg, Germany
Krankenhaus Hedwigshöhe
Berlin, Germany
Hannover Medical School
Hannover, Germany, 30625
Asklepios Fachklinikum Lübben
Lübben, Germany
Asklepios Fachklinikum Teupitz
Teupitz, Germany
Sponsors and Collaborators
Hannover Medical School
Investigators
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Principal Investigator: Helge Frieling, Prof., MD Hannover Medical School

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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT02374567     History of Changes
Other Study ID Numbers: GAP-2014
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hannover Medical School:
geriatric psychiatry
pharmacovigilance

Additional relevant MeSH terms:
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Disease
Psychophysiologic Disorders
Schizophrenia
Anxiety Disorders
Somatoform Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Topiramate
Diphenhydramine
Promethazine
Pregabalin
Lamotrigine
Lacosamide
Carbamazepine
Phenytoin
Oxcarbazepine
Nicergoline
Midazolam
Diazepam
Triazolam
Acamprosate
Gabapentin
Duloxetine Hydrochloride
Amitriptyline
Methotrimeprazine
Levetiracetam
Valproic Acid