Table 2.
Double-blind trials of risperidone in bipolar disorder
| Authors | Study phase | Number of subjects | Duration | Efficacy results |
|---|---|---|---|---|
| Segal et al (1998) | mania: monotherapy | 45 | 28 days | risperidone = haloperidol = lithium |
| Sachs et al (2002) | mania: mixed combination with mood stabilizer | 156 | 3 weeks | risperidone, haloperidol > placebo |
| Yatham et al (2003) | mania: mixed combination with mood stabilizer | 151 | 3 weeks | risperidone = placebo excluding carbamazepine group
risperidone + mood stabilizer > mood stabilizer alone |
| Hirschfeld et al (2004) | mania: monotherapy | 259 | 3 weeks | risperidone > placebo |
| Petrie et al (2004) | mania: mixed combination with mood stabilizer | 37 | 8 weeks | risperidone = olanzapine |
| Khanna et al (2005) | mania: mixed monotherapy | 290 | 3 weeks | risperidone > placebo |
| Smulevich et al (2005) | mania: mixed monotherapy | 438 | 3 weeksa | risperidone > placebo |
Adapted from Sajatovic M, Madhusoodanan S, Fuller MA, et al. 2005. Risperidone for bipolar disorders. Expert Rev Neurother, 5:177–87. Copyright © 2005, with permission from Future Drugs Ltd.
a
3-week placebo controlled followed by 9-week double-blind risperidone vs haloperidol.