- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01786369
Adherence in Patients Admitted to a Psychiatric Unit for Acute Psychosis: an Analysis of Serum Levels of Antipsychotics.
13. april 2015 opdateret af: Leonardo Lopez, Northwell Health
Determination of Adherence in Patients Admitted to a Psychiatric Unit for Decompensated Psychosis: an Analysis of Serum Levels of Antipsychotics.
This is a screening study aimed at estimating the frequency of antipsychotic non-compliance in patients with a history of schizophrenia or other psychotic disorder admitted to an inpatient psychiatric unit.
Levels of the antipsychotics risperidone, olanzapine, quetiapine, aripiprazole, and paliperidone will be drawn in patients presenting the emergency room who are acutely psychotic, require admission to an inpatient hospital, have a history of psychosis, and have previously been prescribed one of the study drugs.
Levels will then be analyzed to determine the frequency and severity of non-compliance in this population.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
We hypothesize that a majority of patients admitted to an inpatient psychiatric service for an acute exacerbation of schizophrenia, schizoaffective disorder, or bipolar I disorder will have plasma levels of antipsychotic below the lower threshold of the accepted therapeutic range as determined by the Arbeitsgemeinschaft fur Neuropsychopharmakologie und Pharmakopsychiatrie (AGNP).
We aim to estimate the frequency of total and partial non-compliance with antipsychotics in adults with schizophrenia, schizoaffective disorder, or bipolar I disorder who are admitted to an inpatient psychiatric service with psychosis.
In order to do so, we will measure serum levels of five commonly prescribed antipsychotics (risperidone, olanzapine, quetiapine, paliperidone and aripiprazole) drawn in the emergency room setting to establish the degree of compliance in admitted patients.
On admission to the inpatient psychiatry service, blood is routinely drawn on all patients via single venipuncture for review of basic laboratory values; 2 tubes are typically drawn.
Investigators will collect a third tube (approximately 2-3 mLs) on all patients prescribed one of the above medications who are admitted with a psychotic decompensation.
This will continue until 100 patients are enrolled.
The extra blood will be sent for determination of serum level of the drug in question.
Each subject will be assigned a unique identification number generated by the principle investigator, and data will be coded using this number.
The following data: age, gender, ethnicity, body mass index, specific diagnosis, and prescribed dosage of the drug in question will be obtained from the subject's medical records.
We will then use the AGNP expert group consensus guidelines for therapeutic drug monitoring to determine the degree of compliance in the specific patient.
All data will be obtained from information available to the clinician (demographic data and previous dosing) or obtained from the small additional blood sample.
Samples will not be stored for future use; residual samples will be destroyed.
For the purposes of this exploratory pilot study we are primarily interested in determining the proportion of patients receiving any of five antipsychotic drugs who have blood levels below an expected therapeutic range.
100 subjects will permit an initial estimate with reasonable confidence intervals.
We will also carry out exploratory analyses to examine the relationship between lower than expected blood levels and diagnostic and demographic patient characteristics.
This will help to inform future research projects and clinical initiatives.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
106
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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Glen Oaks, New York, Forenede Stater, 11004
- Zucker Hillside Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adults with schizophrenia, schizoaffective disorder, or bipolar 1 disorder presenting to a psychiatric emergency room for acute psychosis and requiring inpatient hospital admission.
Beskrivelse
Inclusion Criteria:
- 18 years or older
- Documented diagnosis of schizophrenia, schizoaffective disorder, or bipolar 1 disorder
- Admitted to an inpatient psychiatric unit at Zucker Hillside Hospital for a psychotic decompensation.
- Outpatient for at least one month prior to admission
- On a regimen including risperidone, olanzapine, quetiapine, paliperidone or aripiprazole
Exclusion Criteria:
- Anti-psychotic polypharmacy
- Diagnosis of Mental Retardation or Pervasive Developmental Disorder
- Administrations of any of study medications in emergency room prior to blood draw.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Admitted Patients with Acute Psychosis
Patients 18 years of age or older with a documented diagnosis of schizophrenia, schizoaffective disorder, or bipolar 1 disorder who are admitted to an inpatient psychiatric unit at Zucker Hillside Hospital for a psychotic compensations.
Patients must have been in the outpatient setting for at least one month prior to admission on a regimen including risperidone, olanzapine, quetiapine, paliperidone or aripiprazole.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Serum concentration of risperidone/9-OH-risperidone/olanzapine/quetiapine/aripiprazole
Tidsramme: 6 months
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Leonardo V Lopez, M.D., Northwell Health
- Studieleder: John M Kane, M.D., Northwell Health
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2013
Primær færdiggørelse (Faktiske)
1. april 2015
Studieafslutning (Faktiske)
1. april 2015
Datoer for studieregistrering
Først indsendt
5. februar 2013
Først indsendt, der opfyldte QC-kriterier
5. februar 2013
Først opslået (Skøn)
7. februar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11-384B
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .