This is a double blind placebo controlled study which attempts to evaluate the relative efficacy of intermittent antipsychotic drug administration (given only when prodromal signs of relapse appear) and maintenance medication for stable schizophrenic outpatients. The study had been funded for five years but due to delays in enrolling patients, it will take 1 1/2 more years to complete the project. One hundred and forty patients entered the drug washout phase of the study, and 101 patients were randomized into the intermittent or maintenance groups. By the end of Year 6, all patients will have completed the study protocol, and six months are allocated for analysis of data. The study has already demonstrated that the intermittent approach is safe with little apparent increased risk of rehospitalization for those on placebo. To date 17 patients have been hospitalized, 7 on active medication and 10 on placebo. It also has been determined that patients on active medication are on significantly more medication than those on placebo during the course of the study. Those on placebo are off active medication most of the time. Since feasibility has been established, the important issues are efficacy and the ability to determine which patients are appropriate for the intermittent approach. We will continue to analyze data regarding prodromal episodes in order to determine the severity of symptoms and the duration of the episodes comparing those on maintenance medication and those on placebo. Other important issues are to compare groups regarding the severity of symptomatology and impairment of role functioning, family burden, and incidence and severity of tardive dyskinesia.
| Herz, M I; Glazer, W M; Mostert, M A et al. (1991) Intermittent vs maintenance medication in schizophrenia. Two-year results. Arch Gen Psychiatry 48:333-9 |
