Background Accumulating evidence shows that homocysteine (Hcy) is implicated in the pathophysiology of schizophrenia, and plays an important role in clinical characteristics. This study evaluated the relationships between Hcy levels and clinical features in first-episode, Chinese Han, drug-naïve (FEDN) patients with schizophrenia. Methods FEDN individuals (119 with schizophrenia and 81 healthy controls matched for age, sex, education, and body mass index (BMI)) were enrolled. The serum Hcy levels were determined by enzyme cycle assay experiments. Severities of clinical symptoms were rated on the Positive and Negative Syndrome Scale (PANSS). Results FEDN individuals with schizophrenia had higher Hcy levels compared with healthy controls (F = 46.865, P < 0.001). Correlation analysis and multiple stepwise regression analyses showed that serum Hcy levels in FEDN schizophrenia individuals were positively correlated with PANSS general psychopathology subscale (r = 0.294, P = 0.001) and PANSS total score (r = 0.273, P = 0.003). No significant association was found between Hcy and age, BMI, PANSS positive subscale, and the PANSS negative subscale (all, P > 0.05). Male individuals had significantly higher serum Hcy levels than female individuals (F = 7.717, P = 0.006) after controlling for confounding factors (F = 0.759, P = 0.011). Conclusions Serum Hcy levels were increased in FEDN individuals with schizophrenia, and Hcy levels may be involved in pathophysiological mechanisms. Sex differences in Hcy levels were observed, with higher levels in male FEDN individuals compared to females.

Background Ziprasidone mesylate injection is an atypical antipsychotic drug which is recently approved in China. In combination with its oral formulation, sequential therapy with ziprasidone brings new interventions to patients with agitation in the acute phase of schizophrenia. The purpose of this 7-day multicenter study conducted in China was to evaluate the efficacy and safety of ziprasidone sequential treatment through intramuscular/oral routes in agitated patients with schizophrenia. Methods A total of 95 patients were enrolled from three centers in this study. The study duration was 7 days. In the first 3 days, subjects were administered an intramuscular injection of ziprasidone 10–40 mg daily and started sequentially with oral ziprasidone 40–80 mg at dinner (or lunch) from the day of the last intramuscular injection. In the following 4 days, according to the severity of the symptoms and the drug response, 120–160 mg of ziprasidone was orally administered daily. In total, six visits were scheduled to assess the Positive and Negative Syndrome Scale (PANSS), the Behavioral Activity Rating Scale (BARS), the Clinical Global Impression of Severity (CGI-S), and Improvement (CGI-I) scores throughout the procedure. Lastly, adverse events were recorded during treatment. Results Out of the 95 patients that were enrolled, 83 cases were effectively completed. Visits 3, 4, 6, PANSS, and PANSS-excited component (PANSS-EC) subscale points, and Visit 2–Visit 6 viewpoints, BARS scale points, and baseline scores denote a progressive downward trend (P < 0.001). In this study, 62 adverse events were reported. The most common adverse events were extrapyramidal symptoms (EPS) (23 cases) and excessive sedation(10 cases), and 13 cases of prolonged QTc interval were reported. Conclusions Ziprasidone IM demonstrated significant and rapid reduction in agitation, and sequential oral formulation keep stability and continuation of the treatment can further ensure efficacy. Ziprasidone sequential therapy may provide a new approach to acute agitation in schizophrenic patients. Trial registration The Chinese Clinical Trials Registry; URL: https://www.chictr.org.cn: ChiCTR-OIC-16007970.

Background Accumulating evidence shows that homocysteine (Hcy) is implicated in the pathophysiology of schizophrenia, and plays an important role in clinical characteristics. This study evaluated the relationships between Hcy levels and clinical features in first-episode, Chinese Han, drug-naïve (FEDN) patients with schizophrenia. Methods FEDN patients (119 with schizophrenia and 81 healthy controls matched for age, sex, education, and body mass index (BMI)) were enrolled. The serum Hcy levels were determined by enzyme cycle assay experiments. Severities of clinical symptoms were rated on the Positive and Negative Syndrome Scale (PANSS). Results FEDN patients with schizophrenia had higher Hcy levels compared with healthy controls (F = 46.865, P < 0.001). Correlation analysis and multiple stepwise regression analyses showed that serum Hcy levels in FEDN schizophrenia patients were positively correlated with PANSS general psychopathology subscale (r = 0.294, P = 0.001) and PANSS total score (r = 0.273, P = 0.003). No significant association was found between Hcy and age, BMI, PANSS positive subscale, and the PANSS negative subscale (all, P > 0.05). Male patients had significantly higher serum Hcy levels than female patients (F = 7.717, P = 0.006) after controlling for confounding factors (F = 0.759, P = 0.011). Conclusions Serum Hcy levels were increased in FEDN patients with schizophrenia, and Hcy levels may be involved in pathophysiological mechanisms. Sex differences in Hcy levels were observed, with higher levels in male FEDN patients compared to females.