Real-World Effectiveness and Safety of Antipsychotics in Individuals at Clinical High-Risk for Psychosis: Study Protocol for a Prospective Observational Study (ShangHai at Risk for Psychosis-Phase 2)

Abstract

GuiSen Wu,1 RanPiao Gan,1 ZhiXing Li,1 LiHua Xu,1 XiaoChen Tang,1 YanYan Wei,1 YeGang Hu,1 HuiRu Cui,1 HuiJun Li,2 YingYing Tang,1 Li Hui,3 XiaoHua Liu,1 ChunBo Li,1 JiJun Wang,1,4,5 TianHong Zhang1 1Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai 200030, People’s Republic of China; 2Florida a & M University, Department of Psychology, Tallahassee, FL 32307, USA; 3Institute of Mental Health, The Affiliated Guangji Hospital of Soochow University, Soochow University, Suzhou 215137, Jiangsu, People’s Republic of China; 4Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders (Ministry of Education), Shanghai, People’s Republic of China; 5Brain Science and Technology Research Center, Shanghai Jiao Tong University, Shanghai, People’s Republic of ChinaCorrespondence: TianHong Zhang; JiJun WangShanghai Key Laboratory of Psychotic Disorders (No.13dz2260500), Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders (Ministry of Education), Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, 600 Wanping Nan Road, Shanghai 200030, People’s Republic of ChinaTel [phone]Fax [phone]Email [email protected]: The clinical high-risk (CHR) state is identified as a critical period for early prevention and intervention during the development of psychosis and early treatment may reduce the risk of conversion to psychosis. However, it remains controversial whether antipsychotics are effective in CHR populations. Limited previous randomised controlled trials of antipsychotic treatment of CHR individuals indicated possible short-term efficacy on psychotic symptoms with unclear long-term effects. To answer this question, it is necessary to establish a high-quality real-world cohort study with large sample size to explore the effectiveness and safety of antipsychotics in CHR individuals.Methods: We plan to consecutively recruit 600 CHR individuals from Shanghai Mental Health Centre in the ongoing SHARP-2 (ShangHai At Risk for Psychosis-Phase 2) project between 2019 and 2022. At baseline, participants will be assessed by the Structured Interview for Prodromal Syndromes, the MATRICS Consensus Cognitive Battery, demographic information, and clinical medication history. They will be followed up in a naturalistic way in which the research team will not prescribe antipsychotics or provide pharmacological consultation. First, CHR participants and their families will be trained to record their medication daily and self-evaluate symptoms through smart-phone application-based assessment and report their information weekly. Second, telephone calls will be arranged monthly so that the researchers are informed about the participants’ symptoms, medications and daily functions. Third, face-to-face interviews will be conducted annually for repeating assessment of baseline. The primary outcomes will include conversion to psychosis and functional outcome (scored with less than 60 in the Global Assessment of Function) at the end of the follow-up period.Conclusion: The current study will improve our knowledge on the effectiveness and safety of the use of antipsychotics at the prodromal phase, and will eventually facilitate optimisation of individualised interventions for psychosis prevention and treatment.Keywords: clinical high-risk, early interventions, antipsychotics, subgroup

Keywords

• clinical high-risk
• early interventions
• antipsychotics
• subgroup