Subjective evaluation of the treatment with Serdolect and the effect on functional capacity in patients with schizophrenia - results of a post-marketing study
Abstract
Sertindole is an antipsychotic drug that proved solid efficacy on symptoms of schizophrenia in registration studies. The aim of the present study was the analysis of the sertindole effect on the functional capacity and subjective evaluation of the treatment of schizophrenia patients and their relationship to effectiveness of the treatment in order to understand the effect of sertindole treatment on the whole spectrum of problems caused by schizophrenia.
Methods: post marketing observational open six-month study in patients with schizophrenia. Functional capacity was assessed at the beginning and at the end of the study in "Self-care", "Occupation", "Family life", "Social life" domains.
Subjective evaluation of the treatment was assessed using Drug Attitude Inventory (DAI-10) in the 6th week and the 6th month of the treatment. Illness severity and improvement were assessed using Clinical Global Impression scale (CGI).
Data were analyzed on the observed cases basis. Results: 246 patients were included, 223 (90.7 %) of them completed the 6-month treatment.
During the treatment period both objective and subjective evaluation of functional capacity improved in all domains. The mean DAI-10 score was 6.1 and 7.5 in the 6th week and the 6th month, respectively (p<0.001).
DAI-10 correlated negatively with CGI-I. Patients with dysphoric DAI-10 score more likely dropped out of the long-term treatment.
Conclusion: Sertindole treatment leads to functional capacity improvements of schizophrenia patients. Subjective evaluation of the treatment improves during the long-term treatment and correlates with the magnitude of the clinical state changes.