Pharmacovigilance in Gerontopsychiatric Patients

Pharmacovigilance in Gerontopsychiatric Patients

Sponsors

Lead Sponsor: Hannover Medical School

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.

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

Measure	Time Frame
Assessment of frequency and severity of adverse events	Participants will be followed for the duration of hospital stay and the follow-up-visit, an expected average of 6 weeks

Secondary Outcome

Measure	Time Frame
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

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

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

Overall Official

Last Name	Role	Affiliation
Helge Frieling, Prof., MD	Principal Investigator	Hannover Medical School

Location

Facility:

Bezirkskrankenhaus Augsburg | Augsburg, Germany

Krankenhaus Hedwigshöhe | Berlin, Germany

Hannover Medical School | Hannover, 30625, Germany

Asklepios Fachklinikum Lübben | Lübben, Germany

Asklepios Fachklinikum Teupitz | Teupitz, Germany

Location Countries

Germany

Verification Date

February 2018

Responsible Party

Type: Sponsor

Keywords

Has Expanded Access

No

Condition Browse

Number Of Arms

1

Arm Group

Label: Psychiatric drugs

Type: Experimental

Acronym

GAP

Patient Data

No

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov