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DementiaPhase 3GAPNCT02374567

Pharmacovigilance in Gerontopsychiatric Patients

A Phase 3 study testing Phenobarbital, Phenytoin and Carbamazepine in people with Dementia and Depression, run by Hannover Medical School at 5 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dementia, Depression, Schizophrenia
What is being tested?
Phenobarbital, Phenytoin and Carbamazepine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
407 participants
Where
5 sitesGermany
Study dates
Jan 2015to 28 Jun 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age 65+ years old
  • Inpatients treated at one of the geriatric psychiatry study sites.
  • Signed consent form ( Patient and/or legally authorized custodian)

Who cannot join

  • Patients that are incapable to give their informed consent and are not under legally authorized custodianship.
  • Parallel participation in another clinical trial.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Bezirkskrankenhaus Augsburg

    Augsburg

  • Krankenhaus Hedwigshöhe

    Berlin

  • Hannover Medical School

    Hanover, 30625

  • Asklepios Fachklinikum Lübben

    Lubin

  • Asklepios Fachklinikum Teupitz

    Teupitz

Other trials in Germany

About this study

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.

Read more

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.

Being tested
Phenobarbital, Phenytoin, Carbamazepine, Oxcarbazepine, Valproic Acid
Keywords
geriatric psychiatry, pharmacovigilance
Medical subject headings
Dementia, Depression, Schizophrenia, Psychophysiologic Disorders, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhenobarbitalDrug

  • PhenytoinDrug

  • CarbamazepineDrug

  • OxcarbazepineDrug

  • Valproic AcidDrug

  • LamotrigineDrug

  • TopiramateDrug

  • GabapentinDrug

  • LevetiracetamDrug

  • PregabalinDrug

  • LacosamideDrug

  • ClonazepamDrug

  • BiperidenDrug

  • LevomepromazineDrug

  • FluphenazineDrug

  • PerphenazineDrug

  • PerazineDrug

  • ThioridazineDrug

  • HaloperidolDrug

  • MelperoneDrug

  • PipamperoneDrug

  • BromperidolDrug

  • BenperidolDrug

  • SertindoleDrug

  • ZiprasidoneDrug

  • FlupentixolDrug

  • ChlorprothixeneDrug

  • ZuclopenthixolDrug

  • FluspirileneDrug

  • PimozideDrug

  • ClozapineDrug

  • OlanzapineDrug

  • QuetiapineDrug

  • SulpirideDrug

  • TiaprideDrug

  • AmisulprideDrug

  • ProthipendylDrug

  • RisperidoneDrug

  • AripiprazoleDrug

  • PaliperidoneDrug

  • DiazepamDrug

  • OxazepamDrug

  • LorazepamDrug

  • BromazepamDrug

  • ClobazamDrug

  • AlprazolamDrug

  • HydroxyzineDrug

  • BuspironeDrug

  • Chloral HydrateDrug

  • FlurazepamDrug

  • NitrazepamDrug

  • TriazolamDrug

  • LormetazepamDrug

  • TemazepamDrug

  • MidazolamDrug

  • BrotizolamDrug

  • ZopicloneDrug

  • ZolpidemDrug

  • ZaleplonDrug

  • MelatoninDrug

  • ClomethiazoleDrug

  • DiphenhydramineDrug

  • PromethazineDrug

  • ImipramineDrug

  • ClomipramineDrug

  • OpipramolDrug

  • TrimipramineDrug

  • AmitriptylineDrug

  • NortriptylineDrug

  • DoxepinDrug

  • MaprotilineDrug

  • Amitriptyline oxideDrug

  • FluoxetineDrug

  • CitalopramDrug

  • ParoxetineDrug

  • SertralineDrug

  • FluvoxamineDrug

  • EscitalopramDrug

  • TranylcypromineDrug

  • MoclobemideDrug

  • MianserinDrug

  • TrazodoneDrug

  • MirtazapineDrug

  • BupropionDrug

  • VenlafaxineDrug

  • ReboxetineDrug

  • DuloxetineDrug

  • AgomelatineDrug

  • PyritinolDrug

  • PiracetamDrug

  • DonepezilDrug

  • RivastigmineDrug

  • GalantamineDrug

  • MemantineDrug

  • NicergolineDrug

  • AcamprosateDrug

  • LithiumDrug

Study groups in NCT02374567
Study groupRoleWhat they receive
Psychiatric drugsExperimentalNot described
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of frequency and severity of adverse events

    Measured: Participants will be followed for the duration of hospital stay and the follow-up-visit, an expected average of 6 weeks

Secondary outcomes (6)

  1. Assessment of cognitive functioning

    Mini mental state examination, intensive care delirium checklist

    Measured: At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)

  2. Quality of life

    SF-8

    Measured: At baseline visit and at the final visit (expected average of hospital stay: 4 weeks)

  3. Adverse drug reactions

    Dosage record and treatment emergent symptoms scale (DOTES), geriatric adverse event rating scale (GEARS)

    Measured: Continuously during hospital stay (expected average of hospital stay: 4 weeks) and at follow-up two weeks after discharge

  4. Serum level of substances

    Measured: 1 day at occurrence of SAR

  5. Electrocardiogram

    Measured: At baseline visit, at occurrence of SAR and at the final visit (expected average of hospital stay: 4 weeks)

  6. Medication intake

    Morisky medication adherence scale (MMAS) and chart review

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2015 (estimated)
  2. Study startJan 2015
  3. Primary completion28 Jun 2017
  4. Study completion28 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02374567
Sponsor's protocol ID
GAP-2014
Acronym
GAP
Status last verified
Feb 2018
First submitted
5 Jan 2015
Last updated
28 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Phenobarbital, Phenytoin and Carbamazepine in people with Dementia and Depression, run by Hannover Medical School at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02374567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.

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