Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least
one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly
assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of
oral antipsychotic medication (i.e., excluding other long-acting injectable medications, but
not specifying any particular oral agents or dosages). Recruitment would take 27 months to
complete, and the study would continue for a third year to allow 9 months of follow-up for
the last patient recruited. All patients would be treated from the time of entry up to the
end of the three-year study period. Follow-up assessments would continue quarterly.
Treatments would not be blinded since giving placebo injections to the comparison group would
interfere with the goal of comparing the acceptability of two different methods of medication
administration. However, end points will be blindly rated.
Phase:
Phase 3
Details
Lead Sponsor:
US Department of Veterans Affairs VA Office of Research and Development