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

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.

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.