<p>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)</p>

Abstract

Background: 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 applicationbased 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.

Automatic auditory processing features in distinct subtypes of patients at clinical high risk for psychosis: Forecasting remission with mismatch negativity

“…The HC having a past or current DSM‐IV Axis I disorder or a first‐degree relative with a psychotic disorder were excluded. Further details of the recruitment procedure have been provided in previous publications (Wu et al, 2019 ; Zhang et al, 2014 ). This study was approved by the institutional review board of the Shanghai Mental Health Center (SMHC).…”

Antipsychotic prescription, assumption and conversion to psychosis: resolving missing clinical links to optimize prevention through precision

“…The methodology and study design of the SHARP-extended have been described in detail elsewhere 44 – 47 . Six hundred CHR individuals were recruited between 2016-2019 year at the Shanghai Mental Health Center(SMHC) in China(Clinical trials.gov identifier NCT04010864) 48 . The Research Ethics Committees at the SMHC approved this study.…”