Treatment of schizophrenia requires long-term interventions that address the range of problems that the illness generates. Continuous receipt of antipsychotic medication is the bedrock on which all other interventions for schizophrenia rest and lack of adherence to a consistent medication regimen characterizes many patients over the long-term. The potential benefits of long acting medication that does not require daily self administration has only been available with first generation antipsychotics. In the United States, these medications have generally been reserved for patients who have demonstrated histories of non-compliance and repeated relapse. There is now a long acting form of one of the second-generation ('atypical') antipsychotics - risperidone microspheres. The availability of a medication that does not share either the side effect burden or the stigma associated with old long acting medications represents a major development in the treatment of schizophrenia. Evaluating the impact of the first available long-acting second-generation is therefore timely, innovative, and of considerable public health significance. With such a formative development for our field, it will be particularly important for clinicians and patients alike to acquire information on relapse prevention that is independent of pharmaceutical support in a manner comparable to prior relapse prevention studies of first generation antipsychotic medications. This eight site collaborative R01 proposes to investigate in an effectiveness, """"""""modern-day"""""""" relapse prevention design, whether a long acting second generation medication offers advantages compared to oral second-generation medication. Three hundred four consenting subjects will be randomized to physician's choice oral medication or long acting risperidone, treated for up to two and a half years, and evaluated by masked assessors on measures of psychopathology. Data to be collected will also include time to relapse, level of functioning, service utilization, and medication tolerability. All patients will receive a brief psychoeducational intervention designed to enhance treatment adherence. Even relatively modest delays in relapse and improvement of long term functioning potentially resulting from a long acting second-generation medication can translate into substantial public health benefits.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01MH070017-05
Application #
7768381
Study Section
Special Emphasis Panel (ZMH1-ERB-S (01))
Program Officer
Vitiello, Benedetto
Project Start
2006-02-01
Project End
2011-12-31
Budget Start
2010-04-22
Budget End
2011-12-31
Support Year
5
Fiscal Year
2010
Total Cost
$207,267
Indirect Cost
Name
Beth Israel Deaconess Medical Center
Department
Type
DUNS #
071723621
City
Boston
State
MA
Country
United States
Zip Code
02215
Buckley, Peter F; Schooler, Nina R; Goff, Donald C et al. (2015) Comparison of SGA oral medications and a long-acting injectable SGA: the PROACTIVE study. Schizophr Bull 41:449-59
Manschreck, T C; Merrill, A M; Jabbar, G et al. (2012) Frequency of normative word associations in the speech of individuals at familial high-risk for schizophrenia. Schizophr Res 140:99-103