Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01181960
First received: August 12, 2010
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Bipolar Disorder
Drug: Risperidone long acting injectable - New Starts
Drug: Risperidone long acting injectable - Continuous Users
Drug: Paliperidone Palmitate -New and Continuous Users
Drug: Other Antipsychotics - New Starts
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • The number of psychiatric hospitalizations, non-psychiatric hospitalizations, emergency room visits, and CBHO visits. [ Time Frame: Up to 12 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demographic and related participant information [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • The Structured Clinical Interview for Symptoms of Remission (SCI-SR) will be used to assess remission among participants with schizophrenia. [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Quality of life will be measured using a modified version of the brief version of Lehman's Quality of Life Interview (QOLI). Developed specifically for use with persons with serious mental illness, and assesses satisfaction. [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Psychiatric clinical characteristics will include the age first hospitalized for schizophrenia or bipolar I disorder (as applicable), or the years since first diagnosis. [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • The Personal and Social Performance Scale (PSP) will be used to measure functioning in four key areas: socially useful activities, including work and study; personal and social relationships; self -care; and disturbing behaviors. [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 1066
Study Start Date: August 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
Risperidone long acting injectable - New Starts 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.
Drug: Risperidone long acting injectable - New Starts
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.
002
Risperidone long acting injectable - Continuous Users 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.
Drug: Risperidone long acting injectable - Continuous Users
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.
003
Paliperidone Palmitate -New and Continuous Users Patients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment
Drug: Paliperidone Palmitate -New and Continuous Users
Patients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment
004
Other Antipsychotics - New Starts 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
Drug: Other Antipsychotics - New Starts
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Diagnosed with schizophrenia or bipolar I disorder
  • Antipsychotic use in one of the following categories: Clinician ordered initiation of Risperidone long acting injectable in the 4 weeks prior to or on the day of enrollment (includes patients not previously on any antipsychotic medication and those switched from another antipsychotic)
  • On continuous Risperidone long acting injectable for at least 6 months prior to enrollment (no gaps between injections>30 days)
  • Clinician ordered initiation of Paliperidone Palmitate in the 4 weeks prior to or on the day of enrollment (includes patients not previously on any antipsychotic medication and those switched from another antipsychotic)
  • or on continuous Paliperidone Palmitate for any time period prior to enrollment
  • Clinician ordered initiation of another antipsychotic in the 4 weeks prior to or on the day of enrollment (includes patients not previously on any antipsychotic medication and those switched from another antipsychotic)
  • Not enrolled in another clinical study
  • Primary source of care for schizophrenia or bipolar I disorder is the recruiting CBHO
  • Agrees to all study procedures/interviews
  • must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

  • Currently participating in a clinical study (e.g. clinical trial or observational study) or participated in a clinical study within the past 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181960

  Show 34 Study Locations
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

No publications provided

Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01181960     History of Changes
Other Study ID Numbers: CR017107, RIS-OUT-239
Study First Received: August 12, 2010
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Janssen Scientific Affairs, LLC:
Risperidone long acting injectable
Risperdal Consta
Paliperidone Palmitate
Invega Sustenna

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Risperidone
9-hydroxy-risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 21, 2014