Clinical trial NCT01181960: Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations
Official title: Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Disorder
Keywords: Risperidone long acting injectable
Risperdal Consta
Paliperidone Palmitate
Invega Sustenna
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 1066
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
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.

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

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

Primary outcomes:
measure: The number of psychiatric hospitalizations, non-psychiatric hospitalizations, emergency room visits, and CBHO visits.
timeFrame: Up to 12 months.
Secondary outcomes:
measure: Demographic and related participant information
timeFrame: Baseline, 6 and 12 months
measure: The Structured Clinical Interview for Symptoms of Remission (SCI-SR) will be used to assess remission among participants with schizophrenia.
timeFrame: Baseline, 6 and 12 months
measure: 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.
timeFrame: Baseline, 6 and 12 months
measure: Psychiatric clinical characteristics will include the age first hospitalized for schizophrenia or bipolar I disorder (as applicable), or the years since first diagnosis.
timeFrame: Baseline, 6 and 12 months
measure: 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.
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Bullhead City
country: United States
facility: Neuropsychiatry Clinic and Research Center
state: Arizona
city: Colton
country: United States
facility: Shanti Clinical Trials
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Norwalk
country: United States
facility: South Coast Clinical Trials, Inc.
state: California
city: Aurora
country: United States
facility: Aurora Mental Health Center
state: Colorado
city: Leesburg
country: United States
facility: LifeStream Behavioral Center, Inc.
state: Florida
city: Miami
country: United States
facility: APF Research
state: Florida
city: Macon
country: United States
facility: River Edge Behavioral Health Center
state: Georgia
city: Peoria
country: United States
facility: Human Service Center (Fayette Companies)
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Bloomington
country: United States
facility: Centerstone-Indiana Centerstone Research Institute
state: Indiana
city: Baton Rouge
country: United States
facility: Medical Development Centers LLC (Baton Rouge)
state: Louisiana
city: Opelousas
country: United States
facility: Medical Development Centers LLC (Opelousas)
state: Louisiana
city: Farmington Hills
country: United States
facility: OCCMHA/Community Network Services, Inc.: Oakland County Community Mental Health Authority
state: Michigan
city: Grand Rapids
country: United States
facility: Cherry Street Health Services
state: Michigan
city: Sikeston
country: United States
facility: Bootheel Counseling Services
state: Missouri
city: Springfield
country: United States
facility: Burrell Behavioral Health
state: Missouri
city: St. Louis
country: United States
facility: CenterPointe Institute of Research
state: Missouri
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute
state: Nebraska
city: Manchester
country: United States
facility: The Mental Health Center of Greater Manchester
state: New Hampshire
city: Paramus
country: United States
facility: Bergen Regional Medical Center
state: New Jersey
city: Paterson
country: United States
facility: St Joseph's Regional Medical Center
state: New Jersey
city: Durham
country: United States
facility: Carolina Behavioral Care - Durham [CAREMARK]
state: North Carolina
city: Henderson
country: United States
facility: Carolina Behavioral Care - Henderson
state: North Carolina
city: Hillsborough
country: United States
facility: Carolina Behavioral Care - Hillsborough
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Hospital Dept. of Psychiatry
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Family Services of Western Pennsylvania
state: Pennsylvania
city: Uniontown
country: United States
facility: Chestnut Ridge Counseling Services, Inc.
state: Pennsylvania
city: Charleston
country: United States
facility: South Shore Mental Health Center
state: Rhode Island
city: Pawtucket
country: United States
facility: Human Service Center (Fayette Companies)
state: Rhode Island
city: Nashville
country: United States
facility: Centerstone-Tennessee Centerstone Research Institute
state: Tennessee
city: Arlington
country: United States
facility: Institute for Health Evaluation and Research Unlimited [IHEARU]
state: Texas
city: San Antonio
country: United States
facility: Center for Health Care Services
state: Texas
city: Spokane
country: United States
facility: Frontier Institute-Research Department for Spokane Mental Health
state: Washington
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.