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

NCT01786369 | Completed

• 1 other identifier: 11-384B
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Keywords

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Antipsychotic Agents; Drug Monitoring

Outcome Measures

Primary Outcomes (1)

• Serum concentration of risperidone/9-OH-risperidone/olanzapine/quetiapine/aripiprazole

  6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Anti-psychotic polypharmacy
• Diagnosis of Mental Retardation or Pervasive Developmental Disorder
• Administrations of any of study medications in emergency room prior to blood draw.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Leonardo V Lopez, M.D.

  Northwell Health

  PRINCIPAL INVESTIGATOR

• John M Kane, M.D.

  Northwell Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Resident in Psychiatry

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 7, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

US (1)