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

April 13, 2015 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Serum concentration of risperidone/9-OH-risperidone/olanzapine/quetiapine/aripiprazole
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwell Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leonardo V Lopez, M.D., Northwell Health
  • Study Director: John M Kane, M.D., Northwell Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11-384B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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