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This is a randomized, double-blind, placebo-controlled, clinical multicenter trial. A total of 300 patients with clinical high risk syndrome of psychosis (CHR) will be randomly allocated to SFN group (n=150) or Placebo group (n=150). The intervention duration with SFN or placebo is 52 consecutive weeks. The subsequent follow-up period is another 52 consecutive weeks. The primary endpoints are psychosis conversion rates at the end of intervention period, and one year after intervention. The secondary endpoints include the changes at different time points from baseline to study endpoints in psychotic level symptoms, predicted risk of psychosis, scores of MATRICS consensus cognitive battery, and levels of inflammation, oxidative stress, metabolism through detecting expression of related biomarkers in subjects' peripheral blood.
This study is designed as a randomized, double-blind, placebo-controlled, clinical multicenter trial. The main objective of the study is to evaluate the efficacy of SFN versus placebo for decreasing risk of psychosis in patients with CHR.
A total of 300 patients with CHR will be recruited at Shanghai Mental Health Center, Shanghai Xuhui District Mental Health Center, Shanghai Pudong Nanhui Mental Health Center, Suzhou GuangJi Hospital, The Second Hospital of Xiangya in Changsha, and Guangzhou Huiai Hospital according to the inclusion and exclusion criteria. Informed consent will be obtained from each participant before participation.
CHR subjects meet the Criteria of Prodromal Syndromes (COPS) for the attenuated positive symptom syndrome (APSS), Brief Intermittent Psychotic Syndrome (BIPS), or Genetic Risk and Deterioration Syndrome (GRDS) according to the Structured Interview for Prodromal Syndromes (SIPS). CHR subjects' severity of prodromal symptoms will be assessed according to the Scale of Prodromal Symptoms (SOPS) based on the SIPS interview.
Blocked randomization is conducted for each center. Statistical Analysis System (SAS) Version 9.4 software (SAS Institute, Cary, NC, USA) is applied to generate randomization sequences by a specific statistical researcher who doesn't participate in the clinical trial. Afterwards, the allocation will be sent to each research center. Patients, physicians, researchers, data analyst, and statistician will be blinded to treatment allocation until study completion. Emergency letters containing treatment assignment will also be prepared by specific statistical researcher. Unblinding are only allowed in emergency situations when the participant indeed need further management.
A total of 300 patients with CHR will be randomly allocated to SFN group (n=150) or Placebo group(n=150). The intervention duration with SFN or placebo is 52 consecutive weeks. SFN will delivered as its precursor glucoraphanin (GR) along with a conversion enzyme, myrosinase, which converts GR to SFN in the body (providing the advantage of greater stability and a longer shelf life). Dosage will be adjusted in weight categories as follows: 40-70 kg(4 tablets = 274 μmol GR/day), 70-90kg(6 tablets=411 μmol GR/day). Placebo group will be given placebo tablets, and the number of tablets is determined according to GR and weight conversion. Active tablets and placebo tablets are manufactured uniformly with same shape and color. The subsequent follow-up period after intervention is another 52 consecutive weeks.
Clinical investigators will collect basic data such as gender, age, height, weight, and medical history at baseline. Besides, for safety and study concerns, vital signs and laboratory examination results will be taken, for instance, body temperature, arterial pulse, blood pressure, heart rate, blood routine examination, blood biochemistry, and liver and kidney function tests.
There are two primary endpoints in this study. The first one is psychosis conversion rate at the end of intervention period (52 weeks). The second one is psychosis conversion rate one year after intervention (104 weeks). Conversion is operationalized as the criteria of POPS (Presence of Psychotic Symptoms in SIPS/SOPS). Subjects had to demonstrate at least one psychotic level symptom (rated a '6') on at least one of the five P(Positive) symptoms (P1, unusual thought content; P2, suspiciousness; P3, grandiosity; P4, perceptual abnormalities; and P5, disorganized communication), with either sufficient frequency and duration or at a level that was disorganizing or dangerous. Meanwhile, the Positive and Negative Syndrome Scale (PANSS) was used for rating the severity of symptoms.
The secondary endpoints include the changes at different time points from baseline to study endpoints in psychotic level symptoms, predicted risk of psychosis, scores of MATRICS consensus cognitive battery, and levels of inflammation, oxidative stress, metabolism through detecting expression of related biomarkers in subjects' peripheral blood.
Besides, adverse events, side effects, Brief Adherence Rating Scale (BARS), drugs or therapies combination, and urinary SFN concentration will be detected and recorded.
Clinical High Risk Syndrome of Psychosis
Guangzhou Huiai Hospital
Shanghai Jiao Tong University School of Medicine
Published on BioPortfolio: 2019-05-05T16:45:34-0400
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