RISPERIDONE VERSUS HALOPERIDOL AND AMITRIPTYLINE IN THE TREATMENT OF PATIENTS WITH A COMBINED PSYCHOTIC AND DEPRESSIVE SYNDROME

In a multicenter, double-blind, parallel group trial, the efficacy of risperidone (RIS) was compared with a combination of haloperidol and a mitriptyline (HAL/AMI) over 6 weeks in patients with coexisting psycho tic and depressive symptoms with either a schizoaffective disorder, de pressive type, a major depression with psychotic features, or a nonres idual schizophrenia with major depressive symptoms according to DSM-II I-R criteria. A total of 123 patients (62 RIS; 61 HAL/AMI) were includ ed; the mean daily dosage at endpoint was 6.9 mg RIS versus 9 mg HAL c ombined with 180 mg AMI. Efficacy results for those 98 patients (47 RI S; 51 HAL/AMI) who completed at least 3 weeks of double-blind treatmen t revealed in both treatment groups large reductions in the Positive a nd Negative Syndrome Scale-derived Brief Psychiatric Rating Scale (RIS 37%; HAL/AMI 51%) and the Bech-Rafaelsen Melancholia Scale total scor es (RIS 51%; HAL/AMI 70%). The reductions in the Brief Psychiatric Rat ing Scale and the Bech-Rafaelsen Melancholia Scale scores in the total group were significantly larger in the HAL/AMI group than in the RIS group (p < 0.01), mostly because of significant differences in the sub group of patients suffering from depression with psychotic features, w hereas treatment differences in the other diagnostic subgroups were no t significant. The incidence of extrapyramidal side effects as assesse d by the Extrapyramidal Symptom Rating Scale was slightly higher under RIS (37%) than under HAL/AMI (31%). Adverse events were reported by 6 6% of RIS and 75% of HAL/AMI patients. The results of this trial sugge st that the therapeutic effect of HAL/AMI is superior to RIS in the to tal group of patients with combined psychotic and depressive symptoms. However, subgroup differences have to be considered.