Prediction of functional remission in patients with schizophrenia after antipsychotic discontinuation (FURSAD): protocol for a real-world case-control study

Introduction: Although maintenance treatment is recommended for the prevention of relapse, in real-world settings, a subset of patients discontinue antipsychotics while having a good prognosis. The prediction of functional remission in patients with schizophrenia after antipsychotic discontinuation (FURSAD) study aims to obtain real-world knowledge regarding the characteristics of schizophrenia (SCZ) patients who achieve functional remission after antipsychotic discontinuation for 1 year or more. This study also aims to establish a prediction model to identify patients likely to benefit from antipsychotic discontinuation.

Methods and analysis: The FURSAD study employs a real-world case-control design. Researchers will first screen patients with a diagnosis of SCZ (ICD-10) from the Shanghai Mental Health Center discharged patient pool to identify 480 participants who have been off-antipsychotic for at least 1 year. They will be assigned to the functional remission group or the functional non-remission group according to their social functioning assessment scores, including the self-assessment questionnaire WHO Quality of Life abbreviated version (WHOQoL-BREF) and the peer-assessment scale Functional Remission of General Schizophrenia (FROGS) Scale. Sociodemographic, symptom and treatment information of participants during their hospitalisation and after discharge will be extracted from the Hospital Information System and collected via interviews, respectively, to find independent variables for good prognosis after antipsychotic discontinuation. A nomogram will visualise the prediction model results to help psychiatrists make decisions.

Ethics and dissemination: Full ethical approval for the study (study design, data acquisition license and informed consent) was granted by the ethics committee at Shanghai Mental Health Center, Shanghai, China (approval letter number: 2022-59). The findings of the FURSAD study will be published in peer-reviewed journals or disseminated in conference presentations.

Trial registration number: NCT05667961.