Clinical trial NCT01786369: Adherence in Patients Admitted to a Psychiatric Unit for Acute Psychosis: an Analysis of Serum Levels of Antipsychotics.
Official title: Determination of Adherence in Patients Admitted to a Psychiatric Unit for Decompensated Psychosis: an Analysis of Serum Levels of Antipsychotics.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Keywords: Schizophrenia
Psychotic Disorders
Bipolar Disorder
Antipsychotic Agents
Drug Monitoring
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum concentration of risperidone/9-OH-risperidone/olanzapine/quetiapine/aripiprazole
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: Zucker Hillside Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Leonardo V Lopez, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwell Health
name: John M Kane, M.D.
role: STUDY_DIRECTOR
References: