This is a request for three additional years of funding for the completion of the """"""""Treatment Strategies in Schizophrenia"""""""" study and for the two additional studies that are now being conducted in conjunction with ii (""""""""Lithium Treatment for Schizophrenic Outpatients."""""""" and """"""""Cost Effectiveness Analysis of TSS""""""""). The TSS study has demonstrated the feasibility of the treatments and assessments offered and has received high patient and staff acceptance. Subject completion rates have been lower than originally expect d for several reasons: (1) length of stabilization was extended from 9 weeks in the original protocol to 16-24 weeks, thus extending the time needed to complete the study; (2) rates of stabilization have been lower (60% vs. 90% than originally predicted, thus increasing the number of patients we had to enter into the study in order to have an adequate cohort in the double-blin phase; and (3) some patients were lost to recruitment due to clinician's concerns that these patients should receive a lithium trial. We are not expecting to have enhanced recruitment to the study due to the opening of a new inpatient specialty unit for the in routine SCIDS on all suitable patients, and the availability of the Lithium protocol for patients who are non-responsive to neuroleptics alone which will allay clinicians concerns. Despite the somewhat lower-than- expected patient flow, the study has been productive and promises to provide the field with a great deal of important new information. We have already obtained interesting data on the factors that influence stabilization of schizophrenic subjects and hope to recruit a sample size large enough to enable us to answer the major outcome questio s posed by this study.
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