Safety and related factors of treatment with long-term atypical antipsychotic in Chinese patients with schizophrenia: observational study

Abstract

BackgroundAtypical antipsychotics as first-line drugs have been used in patients with schizophrenia in China and abroad. However, its safety still needs to be evaluated in a large population, especially in Chinese patients.ObjectiveThe main objective of this study is to evaluate the safety and related factors of long-term atypical antipsychotic use in patients with schizophrenia in China. The secondary objective includes the long-term efficacy of atypical antipsychotics in these patients, as well as pharmacoeconomic evaluation, population pharmacokinetic studies and pharmacogenomics studies.MethodsThis study has an observational design. The atypical antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone, amisulpride, perospirone and clozapine. Visits occur at 0, 4, 8, 13, 26, 52, 78, 104, 130 and 156 weeks. The efficacy evaluations include symptoms, social function, recurrence rate and hospitalisation. The safety measures include physical examination, vital signs, abdominal circumference, laboratory tests (such as blood cell analysis, blood biochemical tests and serum prolactin/thyroxine levels), 12-lead ECG, extrapyramidal syndrome assessment, sexual function evaluation, medication and other adverse events. The secondary measures include the Positive and Negative Syndrome Scale, Clinical Global Impression-Severity of Illness Scale, Calgary Depression Scale for Schizophrenia, Personal and Social Performance Scale, relapse rate, drug consolidation, medical-related expenses, income, drug plasma concentration and genetic information.ResultsThis is a large sample, non-interventional and long-term prospective clinical study designed to truly reflect the specific details of clinical practice, fully respect patients’ needs, and understand patients’ treatment intentions and actual treatment details.ConclusionsThis research method details the aims, methods, study design, strengths and limitations of the study.

Plasma metabolomics of schizophrenia with cognitive impairment: A pilot study

“…The patients of the present study were collected from An Observational Study on Atypical Antipsychotics Long-term Treatment Patients with Schizophrenia (SALT-C), a large sample, non-interventional and long-term prospective clinical study in China ( 15 ). The study was approved by the Institutional Review Board of Shanghai Mental Health Center, with the number of 2010-35, 2016-23.…”

“…A total of 842 SCZ patients were recruited for the SALT-C(15). After careful screening, 34 SCZ patients were enrolled in the present study eventually, covering SCZ patients with cognitive impairment (n = 17, it was shown that MoCA < 26 at both time points, group CI), and SCZ patients with cognitive normal (n = 17, MoCA ≥ 26 at both time points, group CN).…”

Changes of Mental State and Serum Prolactin Levels in Patients with Schizophrenia and Depression after Receiving the Combination Therapy of Amisulpride and Chloroprothixol Tablets

“…After that, the data was put through a normal distribution test. The composition ratio should characterize the count data if the data has a normal distribution, and the differences between groups were explored using the chi-square test [11][12][13]. The measurement data should be expressed as (mean standard deviation), the t test should be used to examine the differences between groups, and the physical influencing factors of the case group should be investigated using Logistic regression P0:05 is considered statistically significant.…”

A Real-World Study of Risk Factors for QTc Prolongation in Schizophrenia Patients Receiving Atypical Antipsychotics

“…The study was based on a real-world multicenter clinical trial called An Observational Study on Atypical Antipsychotics Long-term Treatment Patients with Schizophrenia (the SALT-C Study). The protocol of this trial was approved by the Ethics Committee of Shanghai Mental Health Center and assigned to the International Clinical Trials Registry Platform number NCT02640911 10 …”