Open-label assessment of the long-term tolerability, safety, and efficacy of sertindole in patients with schizophrenia

Abstract

Objective:

The primary objective was to assess the long-term tolerability of sertindole.

Methods:

An open-label, flexible-dose, 6 to 18 month study sertindole was conducted at 68 European centres. Patients had a primary diagnosis of schizophrenia (DSM-III-R), and had previously completed an 8-week sertindole/haloperidol comparative study. The long-term tolerability of sertindole was assessed as the proportion of patients reporting an AE judged to be possibly or probably related to sertindole treatment and laboratory parameters, vital signs, and ECG. Long-term response to treatment was evaluated using PANSS and CGI-S.

Results:

295 patients entered the study. 56% of patients received 16 mg sertindole.151 patients completed at least 6 months of treatment. 85 patients withdrew prematurely; withdrawal of informed consent (n=37), lack of efficacy (n=23), and AEs (n=6). 243 patients reported AEs during the study. The most frequent AEs were: asthenia (16%), decreased ejaculatory volume (14%) and metabolic disorder/weight gain (12%). No statistically significant changes in laboratory values or vital signs were observed. Sertindole treatment was associated with a reduction in prolactin, the QTc interval was increased in the 8-week study and decreased over time during the extension study. There was a further treatment-related improvement from the acute study baseline in total PANSS and component subscale scores and CGI-S score.Conclusions: The effective dose for most patients was 16 mg/day. The tolerability profile of sertindole was similar to that seen in earlier studies. The low withdrawal rate due to AEs (2%), indicates that sertindole is well tolerated beyond acute treatment.