Sertindole is associated with a low level of extrapyramidal symptoms in schizophrenic patients: Results of a phase III trial

OBJECT: The objective of this double-blind, multicentre study was to evalua te four noses of sertindole and haloperidol 10 mg. METHOD: The 617 schizophrenic patients were randomized to receive sertindol e 8, 16, 20 or 24 mg/day or haloperidol 10 mg/day. Patients were assessed f or extrapyramidal symptoms (EPS) using the Simpson-Angus Scale (SAS) and Ba rnes Akathisia Scale (BAS), and for movement disorders using the Abnormal I nvoluntary Movement Scale (AIMS). RESULTS: Patients receiving haloperidol experienced significantly more EPS than patients receiving sertindole, supporting observations mane in. previo us studies. The incidence of adverse events was similar for all noses of se rtindole. SAS and BAS scores were significantly worse in the haloperidol,gr oup than in. the sertindole groups. There were significantly greater increa ses in mean QT(c) interval in the sertindole groups than in the haloperidol group. Sertindole did not cause sedation. CONCLUSIONS: Sertindole is well tolerated and does not cause the debilitati ng EPS associated with traditional antipsychotic drugs.