Schizophrenia Clinical Trial
Official title:
Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Janssen Scientific Affairs, LLC |
United States,
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 |
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