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Trial record 11 of 12 for:    pimozide

Pharmacovigilance in Gerontopsychiatric Patients (GAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 5, 2015
First Posted Date  ICMJE March 2, 2015
Last Update Posted Date February 28, 2018
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date June 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02374567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
  • 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
  • Quality of life [ Time Frame: At baseline visit and at the final visit (expected average of hospital stay: 4 weeks) ]
    SF-8
  • 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)
  • 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 [ 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacovigilance in Gerontopsychiatric Patients
Official Title  ICMJE Pharmacovigilance in Gerontopsychiatric Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dementia
  • Depression
  • Schizophrenia
  • Psychosomatic Disorders
  • Anxiety Disorders
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Psychiatric drugs
Interventions:
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 18, 2017)
407
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2015)
2000
Actual Study Completion Date  ICMJE June 28, 2017
Actual Primary Completion Date June 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02374567
Other Study ID Numbers  ICMJE GAP-2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hannover Medical School
Study Sponsor  ICMJE Hannover Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Helge Frieling, Prof., MD Hannover Medical School
PRS Account Hannover Medical School
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP