Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations

• ClinicalTrials.gov Identifier: NCT01181960
• Recruitment Status: Completed
• First Posted: August 13, 2010
• Last Update Posted: February 12, 2014
• Sponsor: Janssen Scientific Affairs, LLC
• Information provided by (Responsible Party): Janssen Scientific Affairs, LLC

Tracking Information

• First Submitted Date: August 12, 2010
• First Posted Date: August 13, 2010
• Last Update Posted Date: February 12, 2014
• Study Start Date: August 2010
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 12, 2010): The number of psychiatric hospitalizations, non-psychiatric hospitalizations, emergency room visits, and CBHO visits. [ Time Frame: Up to 12 months. ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 12, 2010)

• Demographic and related participant information [ Time Frame: Baseline, 6 and 12 months ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations
• Official Title: Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations
• Brief 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
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Schizophrenia
• Bipolar Disorder

Intervention

• 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.
• 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.
• Drug: Paliperidone Palmitate -New and Continuous Users
  Patients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment
• 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

Study Groups/Cohorts

• 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.
  Intervention: Drug: Risperidone long acting injectable - New Starts
• 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.
  Intervention: Drug: Risperidone long acting injectable - Continuous Users
• 003
  Paliperidone Palmitate -New and Continuous Users Patients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment
  Intervention: Drug: Paliperidone Palmitate -New and Continuous Users
• 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
  Intervention: Drug: Other Antipsychotics - New Starts

• Publications *: Joshi K, Mao L, Biondi DM, Millet R. The Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations, Outcomes (REACH-OUT) study: real-world clinical practice in schizophrenia. BMC Psychiatry. 2018 Jan 29;18(1):24. doi: 10.1186/s12888-018-1594-1.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 8, 2013): 1066
• Original Estimated Enrollment (submitted: August 12, 2010): 2450
• Actual Study Completion Date: November 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01181960
• Other Study ID Numbers: CR017107; RIS-OUT-239 ( Other Identifier: Janssen Scientific Affairs, LLC )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Janssen Scientific Affairs, LLC
• Study Sponsor: Janssen Scientific Affairs, LLC
• Collaborators: Not Provided

Investigators

• Study Director: Janssen Scientific Affairs, LLC Clinical Trial; Janssen Scientific Affairs, LLC

• PRS Account: Janssen Scientific Affairs, LLC
• Verification Date: February 2014