A double-blind, randomized, prospective evaluation of the efficacy and safety of risperidone versus haloperidol in the treatment of schizoaffective disorder

The relative efficacy and safety of risperidone versus haloperidol in the t reatment of schizoaffective disorder was studied. Sixty-two patients (29 de pressed type; 33 bipolar type) entered a three-site, randomized, double-bli nd, 6-week trial of risperidone Cup to 10 mg/day) or haloperidol Cup to 20 mg/day). Trained raters assessed baseline, weekly, and end-of-study levels of psychopathology with the Positive and Negative Syndrome Scale (PANSS), t he 24-item Hamilton Rating Scale for Depression (HAM-D-24) and the Clinicia n-Administered Rating Scale for Mania (CARS-M). The authors were unable to statistically distinguish between risperidone and haloperidol in the amelio ration of psychotic and manic symptoms. In addition, there was no differenc e in worsening of mania between the two agents in either subgroup (i.e., de pressed or bipolar subgroups). For the total PANSS, risperidone produced a mean decrease of 16 points from baseline compared with a 14-point decrease with haloperidol. For the total CARS-M scale, risperidone and haloperidol p roduced mean change scores of 5 and 8 points, respectively, and for the CAR S-M Mania subscale, 3 and 7 points, respectively. Additionally, risperidone produced a mean decrease of 13 points from the baseline 24-item HAM-D, com pared with an 8-point decrease with haloperidol. In those patients who had more severe depressive symptoms (i.e., HAM-D baseline score > 20)), risperi done produced at least a 50% mean improvement in 12 (75%) of 16 patients in comparison to 8 (38%) of 21 patients receiving haloperidol. Haloperidol pr oduced significantly more extrapyramidal side effects and resulted in more dropouts caused by any side effect. There was no difference between risperi done and haloperidol in reducing both psychotic and manic symptoms in this group of patients with schizoaffective disorder. Risperidone did not demons trate a propensity to precipitate mania and was better tolerated than halop eridol. In those subjects with higher baseline HAM-D scores (i.e., > 20), r isperidone produced a greater improvement in depressive symptoms than halop eridol.