Pharmacovigilance in Gerontopsychiatric Patients (GAP)

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Schizophrenia; Anxiety Disorders; Dementia; Psychosomatic Disorders
• Intervention / Treatment: Drug: Olanzapine; Drug: Aripiprazole; Drug: Gabapentin; Drug: Melatonin; Drug: Fluoxetine; Drug: Lamotrigine; Drug: Ziprasidone; Drug: Paroxetine; Drug: Topiramate; Drug: Duloxetine; Drug: Escitalopram; Drug: Risperidone; Drug: Sertraline; Drug: Quetiapine; Drug: Clozapine; Drug: Midazolam; Drug: Tranylcypromine; Drug: Diazepam; Drug: Amitriptyline; Drug: Bupropion; Drug: Citalopram; Drug: Venlafaxine; Drug: Pregabalin; Drug: Donepezil; Drug: Galantamine; Drug: Trazodone; Drug: Haloperidol; Drug: Carbamazepine; Drug: Memantine; Drug: Buspirone; Drug: Oxcarbazepine; Drug: Amisulpride; Drug: Levetiracetam; Drug: Clobazam; Drug: Doxepin; Drug: Nortriptyline; Drug: Alprazolam; Drug: Phenytoin; Drug: Oxazepam; Drug: Valproic Acid; Drug: Lithium; Drug: Zolpidem; Drug: Lorazepam; Drug: Imipramine; Drug: Clomipramine; Drug: Mirtazapine; Drug: Diphenhydramine; Drug: Promethazine; Drug: Rivastigmine; Drug: Reboxetine; Drug: Phenobarbital; Drug: Lacosamide; Drug: Clonazepam; Drug: Biperiden; Drug: Levomepromazine; Drug: Fluphenazine; Drug: Perphenazine; Drug: Perazine; Drug: Thioridazine; Drug: Melperone; Drug: Pipamperone; Drug: Bromperidol; Drug: Benperidol; Drug: Sertindole; Drug: Flupentixol; Drug: Chlorprothixene; Drug: Zuclopenthixol; Drug: Fluspirilene; Drug: Pimozide; Drug: Sulpiride; Drug: Tiapride; Drug: Prothipendyl; Drug: Paliperidone; Drug: Bromazepam; Drug: Hydroxyzine; Drug: Chloral Hydrate; Drug: Flurazepam; Drug: Nitrazepam; Drug: Triazolam; Drug: Lormetazepam; Drug: Temazepam; Drug: Brotizolam; Drug: Zopiclone; Drug: Zaleplon; Drug: Clomethiazole; Drug: Opipramol; Drug: Trimipramine; Drug: Maprotiline; Drug: Amitriptyline oxide; Drug: Fluvoxamine; Drug: Moclobemide; Drug: Mianserin; Drug: Agomelatine; Drug: Pyritinol; Drug: Piracetam; Drug: Nicergoline; Drug: Acamprosate

• Study Type: Interventional
• Enrollment (Actual): 407
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Augsburg, Germany
    • Bezirkskrankenhaus Augsburg
  • Berlin, Germany
    • Krankenhaus Hedwigshöhe
  • Hannover, Germany, 30625
    • Hannover Medical School
  • Lübben, Germany
    • Asklepios Fachklinikum Lübben
  • Teupitz, Germany
    • ASKLEPIOS Fachklinikum Teupitz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Psychiatric drugs

Drug: Olanzapine; Drug: Aripiprazole; Drug: Gabapentin; Drug: Melatonin; Drug: Fluoxetine; Drug: Lamotrigine; Drug: Ziprasidone; Drug: Paroxetine; Drug: Topiramate; Drug: Duloxetine; Drug: Escitalopram; Drug: Risperidone; Drug: Sertraline; Drug: Quetiapine; Drug: Clozapine; Drug: Midazolam; Drug: Tranylcypromine; Drug: Diazepam; Drug: Amitriptyline; Drug: Bupropion; Drug: Citalopram; Drug: Venlafaxine; Drug: Pregabalin; Drug: Donepezil; Drug: Galantamine; Drug: Trazodone; Drug: Haloperidol; Drug: Carbamazepine; Drug: Memantine; Drug: Buspirone; Drug: Oxcarbazepine; Drug: Amisulpride; Drug: Levetiracetam; Drug: Clobazam; Drug: Doxepin; Drug: Nortriptyline; Drug: Alprazolam; Drug: Phenytoin; Drug: Oxazepam; Drug: Valproic Acid; Drug: Lithium; Drug: Zolpidem; Drug: Lorazepam; Drug: Imipramine; Drug: Clomipramine; Drug: Mirtazapine; Drug: Diphenhydramine; Drug: Promethazine; Drug: Rivastigmine; Drug: Reboxetine; Drug: Phenobarbital; Drug: Lacosamide; Drug: Clonazepam; Drug: Biperiden; Drug: Levomepromazine; Drug: Fluphenazine; Drug: Perphenazine; Drug: Perazine; Drug: Thioridazine; Drug: Melperone; Drug: Pipamperone; Drug: Bromperidol; Drug: Benperidol; Drug: Sertindole; Drug: Flupentixol; Drug: Chlorprothixene; Drug: Zuclopenthixol; Drug: Fluspirilene; Drug: Pimozide; Drug: Sulpiride; Drug: Tiapride; Drug: Prothipendyl; Drug: Paliperidone; Drug: Bromazepam; Drug: Hydroxyzine; Drug: Chloral Hydrate; Drug: Flurazepam; Drug: Nitrazepam; Drug: Triazolam; Drug: Lormetazepam; Drug: Temazepam; Drug: Brotizolam; Drug: Zopiclone; Drug: Zaleplon; Drug: Clomethiazole; Drug: Opipramol; Drug: Trimipramine; Drug: Maprotiline; Drug: Amitriptyline oxide; Drug: Fluvoxamine; Drug: Moclobemide; Drug: Mianserin; Drug: Agomelatine; Drug: Pyritinol; Drug: Piracetam; Drug: Nicergoline; Drug: Acamprosate

What is the study measuring?

Primary Outcome Measures

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 Measures

Outcome Measure	Measure Description	Time Frame
Assessment of cognitive functioning	Mini mental state examination, intensive care delirium checklist	At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)
Quality of life	SF-8	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)	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	Morisky medication adherence scale (MMAS) and chart review	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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Helge Frieling, Prof., MD, Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 28, 2017
• Study Completion (Actual): June 28, 2017

Study Registration Dates

• First Submitted: January 5, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: pharmacovigilance; geriatric psychiatry
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Anxiety Disorders; Somatoform Disorders; Psychophysiologic Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Central Nervous System Depressants; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Antiemetics; Gastrointestinal Agents; Neuroprotective Agents; Protective Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Cytochrome P-450 Enzyme Inhibitors; Anticonvulsants; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Antidepressive Agents, Tricyclic; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Antimanic Agents; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Serotonin 5-HT3 Receptor Antagonists; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Cytochrome P-450 CYP3A Inducers; Alcohol Deterrents; Dopamine Uptake Inhibitors; Monoamine Oxidase Inhibitors; Antioxidants; Anti-Allergic Agents; Neuromuscular Agents; Sleep Aids, Pharmaceutical; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Nootropic Agents; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP1A2 Inhibitors; Adrenergic Uptake Inhibitors; Adrenergic alpha-Antagonists; Muscle Relaxants, Central; Antiparkinson Agents; Anti-Dyskinesia Agents; Cholinesterase Inhibitors; Adrenergic alpha-2 Receptor Antagonists; Cytochrome P-450 CYP2C19 Inhibitors; GABA Antagonists; GABA-A Receptor Agonists; GABA Agonists; Parasympathomimetics; Olanzapine; Aripiprazole; Midazolam; Buspirone; Sertraline; Duloxetine Hydrochloride; Citalopram; Clomipramine; Gabapentin; Paroxetine; Lamotrigine; Paliperidone Palmitate; Bupropion; Melatonin; Valproic Acid; Diphenhydramine; Promethazine; Pregabalin; Lacosamide; Quetiapine Fumarate; Risperidone; Ziprasidone; S 20098; Diazepam; Amisulpride; Amitriptyline; Brotizolam; Donepezil; Venlafaxine Hydrochloride; Mirtazapine; Nortriptyline; Fluoxetine; Haloperidol; Rivastigmine; Acamprosate; Levetiracetam; Carbamazepine; Oxcarbazepine; Clozapine; Perphenazine; Fluvoxamine; Doxepin; Topiramate; Memantine; Lorazepam; Zolpidem; Alprazolam; Zopiclone; Clonazepam; Trazodone; Tranylcypromine; Phenytoin; Galantamine; Sertindole; Hydroxyzine; Piracetam; Reboxetine; Clobazam; Flurazepam; Temazepam; Phenobarbital; Zaleplon; Oxazepam; Chloral Hydrate; Imipramine; Sulpiride; Triazolam; Pimozide; Mianserin; Moclobemide; Opipramol; Flupenthixol; Flupenthixol decanoate; Biperiden; Nicergoline; Pipamperone; Bromazepam; Nitrazepam; Methotrimeprazine; Chlormethiazole; Lormetazepam; Fluphenazine; Fluphenazine depot; Fluphenazine enanthate; Thioridazine; Clopenthixol; Tiapride Hydrochloride; Chlorprothixene; Fluspirilene; Benperidol; Bromperidol; Perazine; Maprotiline; Trimipramine
• Other Study ID Numbers: GAP-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No