Why the study?
Does sertindole hydrochloride have a favorable safety profile in patients with chronic schizophrenia?
Does sertindole hydrochloride have a favorable safety profile in patients with chronic schizophrenia?
In a small case series, sertindole hydrochloride was well tolerated without acute neurologic side effects, though it caused slight, non-clinically significant QTc prolongation.
Supports short-term tolerability in this case series; leaves open confirmation of favorable safety profile in chronic schizophrenia.
Forty percent of all long-term care hospitalization days are accounted for by patients with schizophrenia. New approaches to managing this disorder are needed, including improved efficacy and better tolerability to enhance compliance with treatment. Sertindole hydrochloride is a novel antipsychotic medication soon to be available in the United States and Canada. As part of multisite phase II and III studies, we studied effects of this medication in five patients with chronic schizophrenia and examined the side effect profile. With more than 30 patient-months of exposure, sertindole treatment was not associated with neurologic side effects and was well tolerated in all patients studied. No evidence of hematologic abnormalities was found. Serial electrocardiograms revealed slight increases in QTc that were not considered clinically significant and did not lead to discontinuance of treatment. While data from larger samples are needed, in this small population sertindol hydrochloride was tolerated well with no evidence of acute neurologic side effects associated with traditional treatments for schizophrenia. Individuals with schizophrenia may benefit from enhanced compliance with treatment and a possible reduction in hospitalizations in the future.
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Brown et al. (1997) studied this question.
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