Sertindole in the long-term treatment of schizophrenia
International Clinical Psychopharmacology, 06/01/2012
Hale AS et al. – Long–term treatment with sertindole was safe and well tolerated, and patients showed clinical improvement beyond acute treatment.Methods
- An open-label, noncomparative, flexible-dose study was carried out in 11 European countries.
- Upon completion of an 8-week, haloperidol-referenced randomized clinical trial with sertindole, patients were offered sertindole maintenance treatment up to 18 months.
- In total, 294 patients were enrolled, of whom 237 (81%) had received sertindole and 57 (19%) had received haloperidol in the lead-in trial.
- The modal dose during the maintenance period was 16 mg/day.
- Patients showed therapeutic improvement indicated by significant decreases in the Positive And Negative Syndrome Scale and Clinical Global Impression ‘severity-of-illness’ scores.
- An adverse event was the primary reason for withdrawal in 13% of patients.
- The most common adverse events were fatigue and weight gain, both with incidences of 14%.
- The incidence of extrapyramidal symptoms was 18%, and 11% of the patients required anticholinergic medication.
- No statistically significant changes were observed in laboratory values or vital signs, but the mean serum prolactin levels decreased.
- The mean change in weight from baseline to the last assessment was 2.7 kg.
- The largest weight increase was observed in patients who were underweight at baseline.