Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations

NCT ID: NCT01181960

Last Updated: 2014-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1066 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-11-30

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

Conditions

Schizophrenia; Bipolar Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Risperidone long acting injectable - New Starts

Intervention Type: DRUG

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.

Risperidone long acting injectable - Continuous Users

Intervention Type: DRUG

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

Paliperidone Palmitate -New and Continuous Users

Intervention Type: DRUG

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

Other Antipsychotics - New Starts

Intervention Type: DRUG

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

Interventions

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 Type: 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.

Intervention Type: DRUG

Paliperidone Palmitate -New and Continuous Users

Patients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Scientific Affairs, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Scientific Affairs, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Scientific Affairs, LLC

Locations

Neuropsychiatry Clinic and Research Center

Bullhead City, Arizona, United States

Shanti Clinical Trials

Colton, California, United States

Sun Valley Research Center

Imperial, California, United States

South Coast Clinical Trials, Inc.

Norwalk, California, United States

Aurora Mental Health Center

Aurora, Colorado, United States

LifeStream Behavioral Center, Inc.

Leesburg, Florida, United States

APF Research

Miami, Florida, United States

River Edge Behavioral Health Center

Macon, Georgia, United States

Human Service Center (Fayette Companies)

Peoria, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Centerstone-Indiana Centerstone Research Institute

Bloomington, Indiana, United States

Medical Development Centers LLC (Baton Rouge)

Baton Rouge, Louisiana, United States

Medical Development Centers LLC (Opelousas)

Opelousas, Louisiana, United States

OCCMHA/Community Network Services, Inc.: Oakland County Community Mental Health Authority

Farmington Hills, Michigan, United States

Cherry Street Health Services

Grand Rapids, Michigan, United States

Bootheel Counseling Services

Sikeston, Missouri, United States

Burrell Behavioral Health

Springfield, Missouri, United States

CenterPointe Institute of Research

St Louis, Missouri, United States

Premier Psychiatric Research Institute

Lincoln, Nebraska, United States

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, United States

Bergen Regional Medical Center

Paramus, New Jersey, United States

St Joseph's Regional Medical Center

Paterson, New Jersey, United States

Carolina Behavioral Care - Durham [CAREMARK]

Durham, North Carolina, United States

Carolina Behavioral Care - Henderson

Henderson, North Carolina, United States

Carolina Behavioral Care - Hillsborough

Hillsborough, North Carolina, United States

Lehigh Valley Hospital Dept. of Psychiatry

Allentown, Pennsylvania, United States

Family Services of Western Pennsylvania

Pittsburgh, Pennsylvania, United States

Chestnut Ridge Counseling Services, Inc.

Uniontown, Pennsylvania, United States

South Shore Mental Health Center

Charleston, Rhode Island, United States

Human Service Center (Fayette Companies)

Pawtucket, Rhode Island, United States

Centerstone-Tennessee Centerstone Research Institute

Nashville, Tennessee, United States

Institute for Health Evaluation and Research Unlimited [IHEARU]

Arlington, Texas, United States

Center for Health Care Services

San Antonio, Texas, United States

Frontier Institute-Research Department for Spokane Mental Health

Spokane, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29378547 (View on PubMed)

Other Identifiers

RIS-OUT-239

Identifier Type: OTHER

Identifier Source: secondary_id

CR017107

Identifier Type: -

Identifier Source: org_study_id