Adherence in Patients Admitted to a Psychiatric Unit for Acute Psychosis: an Analysis of Serum Levels of Antipsychotics.

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• United States
  • New York
    • Glen Oaks, New York, United States, 11004
      • Zucker Hillside Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with schizophrenia, schizoaffective disorder, or bipolar 1 disorder presenting to a psychiatric emergency room for acute psychosis and requiring inpatient hospital admission.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum concentration of risperidone/9-OH-risperidone/olanzapine/quetiapine/aripiprazole	6 months

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Leonardo V Lopez, M.D., Northwell Health; Study Director: John M Kane, M.D., Northwell Health

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Schizophrenia; Bipolar Disorder; Antipsychotic Agents; Psychotic Disorders; Drug Monitoring
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Bipolar Disorder
• Other Study ID Numbers: 11-384B