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Investigator Access
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What's Available
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Research data
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Available Documentation
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Check with study contact or publications for information on a public dataset, data archive, data enclave, or website where data might be available.
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Dates Data are Available
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Currently available, no end date
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Access Criteria
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Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Lauren.Harris2@va.gov. Investigators may be asked to provide further documentation such as a study proposal.
All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.
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Study Characteristics
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Objectives
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Primary
To evaluate the impact of long-acting intramuscular risperidone on risk of inpatient psychiatric hospitalization in comparison to standard oral antipsychotic treatment in Veterans with schizophrenia or schizoaffective disorder
Secondary
To evaluate adherence, health benefits, and costs of long-acting intramuscular risperidone as compared to standard oral antipsychotic treatment as measured by:
- Symptom reduction over 12 months
- Time to all-cause medication discontinuation
- Quality of life
- VA and non-VA health service use and related costs
- Medication side effects
- Violent behavior
- Use of concomitant medication
- Incremental cost-effectiveness ratio
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Era of Service
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All
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Population
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Veterans diagnosed with schizophrenia or schizoaffective disorder based on the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) at risk for hospitalization (91% male, mean age 51)
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Study Design
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Randomized controlled trial with no blinding
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Intervention
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- Long-acting injectable intramuscular risperidone
- Control group continued standard oral treatment
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Time Period
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September 2006 - September 2009
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Setting
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National
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N
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369 participants
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Response Rate
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69.5% (369 out of 531 eligible for participation)
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Recruitment Method
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Inpatients and outpatients with schizophrenia or schizoaffective disorder diagnosis were identified from VA discharge abstracts, with the patients’ Social Security Number were sent to the participating sites. Physicians treating the patients invited them to participate, and patients were screened for eligibility.
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Compensation
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- $25 for monthly injection visits
- $45 for extended quarterly assessment visits
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Data Collected
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- Hospitalization-free survival (time from date of randomization to date of hospitalization)
- Clinical Global Impressions (CGI) scale of mental health status
- Questionnaires for measuring quality of life, satisfaction with medication, symptoms, anxiety, depression, substance abuse, social functioning, and side effects
- Administrative data on health service use, adverse events and mortality
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Data Collection Methods
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- Questionnaire
- Administrative data
- Blinded videoconference assessments
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Funding Sources
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VA Cooperative Studies Program (CSP)
Ortho-McNeil Janssen Scientific Affairs
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Investigators
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Principal Investigator: Robert Rosenheck, MD; Robert.Rosenheck@va.gov
Study Co-Chair: John Krystal, MD; John.Krystal@va.gov
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Contact
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Study Contact: Lauren Harris; Lauren.Harris2@va.gov
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Selected Publications
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Rosenheck, RA, Krystal JH, Lew R, Barnett PG, Fiore L, Valley D, Thwin SS, Vertrees JE, Liang MH; CSP 555 Research Group. Long-Acting Risperidone and Oral Antipsychotics in Unstable Schizophrenia. N Engl J Med. 2011; 364(9): 842-51.
Rosenheck RA, Krystal JH, Lew R, Barnett PG, Thwin SS, Fiore L, Valley D, Huang GD, Neal C, Vertrees JE, Liang MH; CSP 555 Research Group. Challenges in the design and conduct of controlled clinical effectiveness trials in schizophrenia. Clin Trials. 2011 Apr;8(2):196-204
Barnett PG, Scott JY, Rosenheck RA; CSP 555 Study Group. How do clinical trial participants compare to other patients with schizophrenia? Schizophr Res. 2011 Aug;130(1-3):34-9.
Barnett PG, Scott JY, Krystal JH, Rosenheck RA; CSP 555 Research Group. Cost and cost-effectiveness in a randomized trial of long-acting risperidone for schizophrenia. J Clin Psychiatry. 2012 May;73(5):696-702.
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More Information
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ClinicalTrials.gov Identifier: NCT00132314
Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)
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