Sertindole is a non-sedating atypical
antipsychotic effective in the management of
schizophrenia and is associated with placebo-level incidence of extrapyramidal symptoms (EPS). In this randomized, double-blind, parallel-group, flexible-dose, multi-centre study, the efficacy and tolerability of
sertindole was directly compared with another atypical
antipsychotic in patients with
schizophrenia. A total of 187 patients were randomly assigned to treatment with
sertindole (12-24 mg/day, n=98) or
risperidone (4-10 mg/day, n=89) for 12 weeks. Although early termination reduced the power of the study, some significant between-group differences were evident.
Sertindole reduced the mean Positive and Negative Syndrome Scale total scores to a greater extent than
risperidone, and the difference reached statistical significance at endpoint for the Observed Cases (OC) dataset. Moreover,
sertindole was superior for the treatment of negative symptoms compared to
risperidone (P<0.05, Last Observation Carried Forward and OC). Both treatment groups were similarly effective in improving Clinical Global Impression (Severity and Improvement), the
Drug Attitude Inventory and Global Assessment of Functioning scores.
Sertindole and
risperidone were both well tolerated. Numerically, fewer patients in the
sertindole group (19%) reported EPS-related adverse events than in the
risperidone group (28%), although significantly more
sertindole-treated patients reported QT prolongation and abnormal ejaculation volume (P<0.05). In conclusion,
sertindole was well tolerated and demonstrated clinically relevant efficacy advantages over
risperidone.