There was a significant increase in SAS score at week 4, but no significant difference was observed between baseline and the endpoint. At week 24 the mean SAS score was 0.08, which is less than 0.3, the upper limit of the normal range [Simpson and Angus, 1970] (Figure 1). Table 1. Baseline demographic and disease characteristics. Table 2. BPRS total score, SAPS score Inhibitors,research,lifescience,medical and SANS score. Figure 1. Simpson–Angus extrapyramidal side effects Scale (SAS) score change during the treatment period (*p < 0.05). Prolactin levels increased
significantly both in men and women starting from the measurement on day 4 of treatment. There was no significant difference between prolactin levels at weeks 2 and 24 (Figure 2). Prolactin elevation was significantly higher in women than in men starting from day 4. Baseline mean prolactin level was 30.2 ± 19.7 ng/ml for women and 21.3 ± 15.4 ng/ml for men. Prolactin levels increased up to 235.3 ± 68.7 ng/ml in women and 67.9 ± 21.3 ng/ml in men. Of the 18 patients one woman developed amenorrhea, two women developed menstrual
Inhibitors,research,lifescience,medical NVP-AUY922 clinical trial irregularity, one women and one man developed decreased libido and anorgasmia. Sexual function could not be adequately evaluated in two of the patients with a disorganized type of schizophrenia. Figure 2. Prolactin level change during the treatment period (*p < 0.05 starting from day 4). Figure 3. Prolactin level change during the treatment period in male and female patients (*p < Inhibitors,research,lifescience,medical 0.05). There was no significant difference regarding BMI between the first and last visits. Amisulpride is associated with only a slight weight gain of approximately Inhibitors,research,lifescience,medical 0.8 kg within 24 weeks. Total cholesterol levels increased significantly compared with baseline (176.7 ± 35.8) at week 12 (206.8 ± 53.7) and week 24 (194.4 ± 47.6). Inhibitors,research,lifescience,medical LDL cholesterol levels increased significantly compared with baseline (106.4 ± 30.9) at week 12 (130.4 ± 43.8), but this significance did not continue up to week
24 (116.5 ± 39.7). No significant difference from baseline was determined regarding high-density lipoprotein (HDL) cholesterol, TG, apolipoprotein A1, apolipoprotein B1, lipoprotein a, leptin or adiponectin levels or atherogenic indices (total cholesterol / HDL cholesterol and LDL cholesterol / HDL cholesterol). No significant difference from baseline was determined regarding thyroid function tests, sex hormones, ACTH, GH, cortisol, oral glucose tolerance test, insulin and HbA1c. Except for prolactin Carnitine dehydrogenase and sex hormone levels, there was no significant difference between men and women when all of the other blood parameters were compared. Electrocardiograms revealed no QT prolongation during the treatment period. Blood pressure and pulse rate measurements did not differ significantly from baseline. Discussion In this study investigating metabolic, endocrinologic and cardiac effects of amisulpride, it was found that amisulpride was an effective and safe drug except for the fact that it elevates prolactin levels markedly in both sexes.