- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01786369
Adherence in Patients Admitted to a Psychiatric Unit for Acute Psychosis: an Analysis of Serum Levels of Antipsychotics.
13 april 2015 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
106
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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New York
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Glen Oaks, New York, Förenta staterna, 11004
- Zucker Hillside Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adults with schizophrenia, schizoaffective disorder, or bipolar 1 disorder presenting to a psychiatric emergency room for acute psychosis and requiring inpatient hospital admission.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Serum concentration of risperidone/9-OH-risperidone/olanzapine/quetiapine/aripiprazole
Tidsram: 6 months
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6 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Leonardo V Lopez, M.D., Northwell Health
- Studierektor: John M Kane, M.D., Northwell Health
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2013
Primärt slutförande (Faktisk)
1 april 2015
Avslutad studie (Faktisk)
1 april 2015
Studieregistreringsdatum
Först inskickad
5 februari 2013
Först inskickad som uppfyllde QC-kriterierna
5 februari 2013
Första postat (Uppskatta)
7 februari 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
14 april 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 april 2015
Senast verifierad
1 april 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 11-384B
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .