Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Observational

Summary: 
      The purpose of this study is to build a data repository that can be used to understand
      pharmaceutical utilization patterns among patients being treated in community behavioral
      health organizations (CBHOs) for schizophrenia or bipolar I disorder.
    

Detailed description: 
      This is a prospective observational study of usual care of patients undergoing treatment for
      schizophrenia or bipolar I disorder at CBHOs. Up to 50 CBHOs will be selected as sites for
      this study. Treating clinicians at these sites will notify the designated research
      coordinators for this study when they are initiating a patient on a new antipsychotic
      medication (including risperidone long acting injectable or paliperidone palmitate) or if
      they are treating a patient with risperidone long acting injectable or paliperidone
      palmitate. New initiation will include patients not previously on any antipsychotic
      medication as well as those switched from one antipsychotic to another. Switches may include
      but are not limited to switches among different types of oral antipsychotics, from an oral
      antipsychotic to Long Acting Therapy (LAT), or from LAT to an oral antipsychotic. Site
      research staff will screen potential participants identified by the clinicians and enroll
      those meeting study criteria who consent to study participation. Sites will maintain a
      screening log of all potential participants. The target enrollment for this study is up to
      2,450 participants. Enrollment by cohort will be monitored and sites will be notified to stop
      enrollment if target enrollment for a particular cohort has been reached. Eligible
      participants who consent to the study will be recruited into one of two samples: participants
      with a schizophrenia diagnosis (target n=2,250) and participants with a bipolar I disorder
      diagnosis (target n=200). There will be four cohorts: risperidone long acting injectable new
      starts (target n=475); risperidone long acting injectable continuous users (target n=75);
      paliperidone palmitate new starts or continuous users (target n=1,200); and other
      antipsychotic new starts (target n=700). During the entire study follow-up period
      participants will receive their medication per usual care in their treatment setting and no
      study drug will be provided. Enrolled participants will be followed prospectively over a
      12-month study period, with interviews at baseline, 6 and 12 months. Sites will also abstract
      medical history and healthcare utilization information from the chart of each enrolled
      participant. There will be three chart abstractions (baseline, 6 Months, 12 Months). The
      baseline abstraction will cover services rendered in the 6 months prior to antipsychotic
      initiation or switch, or from their first visit to the CBHO if the individual did not receive
      services for as long as 6 months prior to initiation or switch. The 6M and 12M abstractions
      will each cover services rendered in the prior 6 months. When all three abstractions are
      complete, the data will cover the period from 6 months before baseline to 12 months after
      baseline. If a Serious Adverse Event (SAE) associated with a J&J medicinal product occurs the
      investigator will record it in the source document as well as fax the SAE form to J&J
      internal safety group within 24 hours. Treatment as usual
    

Intervention name(s): Risperidone long acting injectable - New Starts; Risperidone long acting injectable - Continuous Users; Paliperidone Palmitate -New and Continuous Users; Other Antipsychotics - New Starts
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Patients who switch to Risperidone long acting injectable or receive an initial injection of Risperidone long acting injectable within the 30 days prior to enrollment will be eligible for inclusion in the Risperidone long acting injectable New Starts cohort.; Patients who have been on Risperidone long acting injectable for at least 6 months before baseline, with no gaps between injections of more than 30 days will be eligible for inclusion in the Risperidone long acting injectable Continuous Users cohort.; Patients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment; Participants in the other antipsychotic cohort may be newly started on any oral or injectable antipsychotic other than Risperidone long acting injectable and Paliperidone Palmitate
Intervention MeSH terms: Risperidone; Paliperidone Palmitate; Antipsychotic Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Potential participants will be identified by treating clinicians at the site. The study
        will enroll participants treated at participating sites for schizophrenia and bipolar I
        disorder. The study does not involve administration of a study drug, but will
        naturalistically follow partticipants in these medication cohorts at the time of
        enrollment: clinician ordered initiation or switch to LAT within past 4 weeks, clinician
        ordered initiation or switch to oral antipsychotic within past 4 weeks, continuous users (
        greater than or equal to 6 months) of Risperdal long acting injectable, continuous users
        (greater than or equal to 1 month) of Invega Sustenna.
      
Keywords: Risperidone long acting injectable; Risperdal Consta; Paliperidone Palmitate; Invega Sustenna