Introduction
RS, decline in psychosocial functioning, impairment of social functioning, anxiety, chronic mental disorder, hyperprolactinemia, depression, psychosis, extrapyramidal adverse, psychotic symptoms, Schizophrenia
HYPERPROLACTINEMIA, ADVERSE EFFECTS
Schizophrenia (SZ) is a severe, chronic mental disorder with a significant decline in psychosocial functioning [Risperidone, one of the atypical antipsychotics used to treat SZ, is recommended as a first-line agent and is an effective treatment strategy to alleviate acute and chronic psychosis in patients with SZ at admission [Risperidone can drastically improve clinical symptoms in patients with SZ, but its role is limited due to the high incidence of hyperprolactinemia and extrapyramidal adverse effects. Exploring new combinations of antipsychotics to improve efficacy and reduce side effects in the treatment of SZ is an interesting topic. To reduce the adverse effects of risperidone, low doses of risperidone can be helpful for patients with SZ. However, there is a need to investigate a new clinical treatment option with fewer adverse effects and better efficacy than standard doses of risperidone. Given the negative symptoms and impairment of social functioning in SZ patients, we chose to use a selective 5-hydroxytryptamine reuptake inhibitor (SSRI) in combination with low-dose risperidone to alleviate symptoms in SZ patients. SSRIs have selective and potent inhibitory effects on presynaptic 5-HT reuptake and increase the 5-HT concentration in the synaptic gap, thereby promoting the action of the 5-hydroxytryptamine system. Importantly, sertraline has been reported to be the most potent SSRI in increasing extracellular DA concentrations in the striatum, and thus improving negative symptoms [In the present study, we hypothesized that a low daily dose of risperidone combined with sertraline would be superior to standard doses of risperidone (4–6 mg/day) in improving psychosocial functioning and reducing adverse effects in FEMN SZ patients. Although risperidone can be utilized up to 16 mg/day, the purpose of this study was to investigate whether low-dose combination therapy would improve negative symptoms and social functioning, and reduce side effects more than the recommended dose of risperidone. Therefore, the manufacture’s recommended dose of risperidone (4–6 mg/day) was chosen for patients in the control group. In this 24 week open-label study, we investigated the following questions in patients with FEMN SZ: (1) to compare the improvement in psychotic symptoms in the low-dose risperidone combined with sertraline group (RS) and the risperidone monotherapy group (control group); (2) to compare the improvement in psychosocial functioning in the RS and control groups; (3) to compare the two groups in terms of improvements in depression and anxiety symptoms; (4) to compare the adverse effects of the two groups; and (5) is improvement in psychosocial functioning associated with a reduction in psychotic symptoms or adverse effects?