Study design and participants
epilepsy, extrapyramidal symptoms, substance abuse, diabetes, malignant tumor, Alzheimer’s disease, Parkinson’s disease, DSM Disorders, Schizophrenia [, comorbid physical diseases, schizophrenia, hepatic or renal dysfunction, DSM-5
DISORDERS, POSITIVE, EPILEPSY, HEART DISEASE, DISEASE, SYNDROME, MULTIPLE SCLEROSIS
The study was an open-labeled, randomized, 24-week longitudinal design from September 2017 to April 2021 at the Second Xiangya Hospital of Central South University. The inclusion criteria were as follows: (1) patients with a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); (2) aged 18–65 who completed more than six years of primary education; (3) patients with a high risk of MetS who gained weight ≥10% of their pre-drug weight within the first year after antipsychotic medication; (4) patients with relatively stable improvement (the total score of the Positive and Negative Syndrome Scale [PANSS] ≤60); (5) disease duration ≤5 years; and (6) and received one or two stable antipsychotics medications without dosage changes during the study period.The exclusion criteria were: (1) patients with significant neurological conditions such as Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, and epilepsy was excluded from the study; (2) a history of substance abuse in the past 12 months; (3) comorbid extrapyramidal symptoms requiring additional medications; (4) received modified electroconvulsive therapy (MECT) or rTMS during the past three months, or need to start MECT/rTMS treatment during the study period; (5) comorbid physical diseases such as hepatic or renal dysfunction, diabetes, malignant tumor, or heart disease; (6) participated in a cognitive treatment program in the past three months or participated in other clinical trials; (7) pregnant or lactating.Written, informed consent was obtained from all participants before any assessments. They then underwent a diagnostic evaluation by two psychiatrists using the Structured Clinical Interview for DSM Disorders (SCID-5) based on the DSM-5 criteria. The study was approved by the Second Xiangya Hospital Ethics Board and was conducted following the FDA-NIMH-Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Guidelines for Clinical Trial Design of Cognitive-Enhancing Drugs for Patients with Schizophrenia [