Changing from Conventional to Risperidone Decanoate

University Of Connecticut Storrs, Storrs-Mansfield CT

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Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): As many as 1 in 5 individuals with schizophrenia taking antipsychotic medications are maintained on a first-generation depot. These individuals may not be candidates for treatment with oral second-generation antipsychotic medications for a variety of reasons, including concerns about medication adherence and patient preference. We know surprisingly little about the expected risks and gains associated with changing from first- to second-generation antipsychotic medications. One currently funded NIMH study (R01MH59312; Susan M. Essock, Ph.D., PI) was designed to examine the effectiveness of staying on a first generation antipsychotic medication versus switching to risperidone, olanzapine, or ziprasidone. Given that the FDA is about to approve a long-acting injectable form of risperidone, we have designed a study to answer this question for those individuals taking first-generation depots. This study would address the following question, "Should people who are relatively stable on one of the first-generation depot antipsychotic medications (fluphenazine or haloperidol) but who are still symptomatic or troubled by medication side effects be switched to long-acting injectable risperidone?" To answer this question, we will examine 236 consenting patients from a large, diverse public mental health system, who are living in the community and taking first-generation depot antipsychotic medications but who are still troubled by symptoms or medication side effects. Subjects will be randomly assigned to stay on their current first-generation depot (N=118) or to change to long-acting injectable risperidone (N=118). All medications will be open label, and treatment will be by the subjects' routine providers. Subjects will be asked to stay in their assigned treatment condition for 6 months, after which time medication decisions will be up to the patient and the prescribing psychiatrist. Subjects will be interviewed with quantitative instruments at baseline and at follow-up intervals for 1 year. [unreadable] [unreadable]