Table 1.
Summary of design decisions for risperidone only versus risperidone ± PT
| Design decision | Rationale |
|---|---|
| No placebo group in acute phase | Efficacy of risperidone already demonstrated; equipoise no longer present |
| No PT only group | Focus on additive effects of PT; not drug versus PT |
| Use of 2:1 randomization | Facilitate recruitment |
| Selection of outcome measuresa | Examine ↓ maladaptive behavior via drug; examine ↑ compliance and adaptive behavior via PT |
| Selection of 24-week randomized trial | Ensure sufficient time for positive effects of PT |
| Use of aripiprazole after failure of risperidone in acute phase | Guard against attrition in the 24-week trial |
| Inclusion of 10-week medication discontinuation phase | Evaluate rate of relapse in drug only versus combined treatment |
a
Home situations questionnaire, Vineland Adaptive Behavior scales, Aberrant Behavior Checklist Irritability subscale, improvement item on the Clinical Global Impressions