Efficacy of low-dose risperidone in combination with sertraline in first-episode drug-naïve patients with schizophrenia: a randomized controlled open-label study - Journal of Translational Medicine

In addition, blood prolactin levels were determined in the hospital laboratory using commercially available kits.Required sample sizes for adequate power were calculated using the G*Power program. Based on a one-sided α of 0.05, a sample size of 102 evaluable patients in each treatment group was needed to identify the effect size of 0.35 at 80% power. Assuming a dropout rate of 10%, a minimum sample of 204 evaluable patients was needed.

A repeated measures multivariate analysis of variance was used to compare the efficacy of the two treatment regimens. For dependent variables, prolactin levels and symptom scores measured at 5 time points were considered as repeated measures within effects, treatment groups were considered as between effects, and age, gender, age at onset, and education were covariates. In each RM-ANOVA model, the independent variables were outcome measures over time.

Data were analyzed using PASW Statistics . Significance was set at p 0.05). In addition, there were no significant differences in PANSS scores, CGI-S, PSP, and HAMD total scores between the two groups . In addition, there was also no difference in prolactin levels between the RS and control groups .

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