Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations

Schizophrenia Clinical Trial

Official title:

Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181960
• Other study ID #: CR017107
• Secondary ID: RIS-OUT-239
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2010
• Last updated: February 11, 2014
• Start date: August 2010
• Est. completion date: November 2013

Study information

• Verified date: February 2014
• Source: Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1066
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

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

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital Dept. of Psychiatry	Allentown	Pennsylvania
United States	Institute for Health Evaluation and Research Unlimited [IHEARU]	Arlington	Texas
United States	Aurora Mental Health Center	Aurora	Colorado
United States	Medical Development Centers LLC (Baton Rouge)	Baton Rouge	Louisiana
United States	Centerstone-Indiana Centerstone Research Institute	Bloomington	Indiana
United States	Neuropsychiatry Clinic and Research Center	Bullhead City	Arizona
United States	South Shore Mental Health Center	Charleston	Rhode Island
United States	Shanti Clinical Trials	Colton	California
United States	Carolina Behavioral Care - Durham [CAREMARK]	Durham	North Carolina
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	Carolina Behavioral Care - Henderson	Henderson	North Carolina
United States	Carolina Behavioral Care - Hillsborough	Hillsborough	North Carolina
United States	Sun Valley Research Center	Imperial	California
United States	LifeStream Behavioral Center, Inc.	Leesburg	Florida
United States	Premier Psychiatric Research Institute	Lincoln	Nebraska
United States	River Edge Behavioral Health Center	Macon	Georgia
United States	The Mental Health Center of Greater Manchester	Manchester	New Hampshire
United States	APF Research	Miami	Florida
United States	Centerstone-Tennessee Centerstone Research Institute	Nashville	Tennessee
United States	South Coast Clinical Trials, Inc.	Norwalk	California
United States	Medical Development Centers LLC (Opelousas)	Opelousas	Louisiana
United States	Bergen Regional Medical Center	Paramus	New Jersey
United States	St Joseph's Regional Medical Center	Paterson	New Jersey
United States	Human Service Center (Fayette Companies)	Pawtucket	Rhode Island
United States	Human Service Center (Fayette Companies)	Peoria	Illinois
United States	Family Services of Western Pennsylvania	Pittsburgh	Pennsylvania
United States	Center for Health Care Services	San Antonio	Texas
United States	Bootheel Counseling Services	Sikeston	Missouri
United States	Frontier Institute-Research Department for Spokane Mental Health	Spokane	Washington
United States	Burrell Behavioral Health	Springfield	Missouri
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	CenterPointe Institute of Research	St. Louis	Missouri
United States	Chestnut Ridge Counseling Services, Inc.	Uniontown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of psychiatric hospitalizations, non-psychiatric hospitalizations, emergency room visits, and CBHO visits.		Up to 12 months.	No
Secondary	Demographic and related participant information		Baseline, 6 and 12 months	No
Secondary	The Structured Clinical Interview for Symptoms of Remission (SCI-SR) will be used to assess remission among participants with schizophrenia.		Baseline, 6 and 12 months	No
Secondary	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.		Baseline, 6 and 12 months	No
Secondary	Psychiatric clinical characteristics will include the age first hospitalized for schizophrenia or bipolar I disorder (as applicable), or the years since first diagnosis.		Baseline, 6 and 12 months	No
Secondary	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.		Baseline, 6 and 12 months	No