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临床试验/NCT03451734
NCT03451734已完成不适用

Optimizing and Individualizing the Pharmacological Treatment of First-episode Schizophrenic Patients

Central South University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年1月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,000
试验地点
1
主要终点
Positive And Negative Syndrome Scale (PANSS)

研究概览

简要总结

The study is performed in 20 different hospitals from 19 cities in China. Three sub-projects are included. About sub-project 1, we build a clinical database system and a biological sample bank for data and samples management, which is applicable in other hospitals in this project. 1800 first-episode schizophrenia patients will be recruited in 19 sites and randomized into 6 treatment groups (olanzapine, risperidone, aripiprazole, ziprasidone, amisulpride, haloperidol). Through 8-week treatment and follow-up, we collect multidimensional indexes from psychopathology, neuropsychology, brain imaging, physiology, biochemistry, and life stress data. The summarized data is analyzed to screen potential biomarkers or biomarker panel that may predict the antipsychotic response, and ultimately to establish a prediction model.Sub-project 2, as an extension of sub-project 1, includes verification of the prediction model established in sub-project 1 and optimization of the current therapy with add-on treatment. Firstly, the validation process of the prediction model undergoes with an independent patient cohort. Next, we apply the add-on treatment to the patients who don't have ideal response to antipsychotic treatment after 8-week treatment. According to the results above, we manage to construct an optimized and individualized therapy for schizophrenia.In the end,We tend to conduct a randomized double-blind controlled trial to assess the safety and efficacy of the combination strategy for antipsychotic-induced metabolism syndrome, which includes metformin and lifestyle intervention. In the meanwhile, for schizophrenia patients at high-risk of metabolic syndrome, we tend to establish a prevention strategy expected to reduce or delay the occurrence of metabolic syndrome, which includes low-dose metformin and lifestyle intervention. We hope to successfully construct a comprehensive intervention strategy on metabolic syndrome induced by antipsychotic medications.

详细描述

For sub-project1 and 2:Inclusion criteria: Participants are ineligible to enter the trial under the following conditions: 1) Participants must be aged 18 to 65 years old who meet the criteria for schizophrenia diagnosed by Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) or International Classification of Diseases- tenth edition (ICD-10); 2) participants are in current episode of psychotic symptoms with a disease course less than 3 years and intermission less than 6 months; 3). there is at least 1 guardian to accompany patient within 1 year; 4). Participants and their guardians must sign an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion criteria (any potential paticipant who meets any of the following criteria will be excluded from participating in the study): 1). Participants with known or suspected clinically unstable systemic medical disorder; 2). participant has a current or prior DSM-5/ ICD-10 diagnosis of substance use disorder, intellectual disability, autism spectrum disorder, dementia or severe cognitive impairment; 3). planning to be pregnant, pregnancy or breast-feeding; 4). currently enrolled in another clinical trial.

For sub-project 3:The diagnostic criteria for Paticipants who develop metabolic syndrome: A. body mass index ≥ 25.0kg / m2; B. hyperglycemia: fasting blood glucose ≥ 110mg/dl (6.1mmol/l) and / or plasma glucose ≥ 140mg/dl(7.8mmol/l) after glucose load; and / or those who have been diagnosed with diabetes and received treatment; C. hypertension: systolic blood pressure (SBP) / diastolic blood pressure (DBP) ≥ 140/90mmHg, and / or those who have been diagnosed as hypertension and received treatment; D. dyslipidemia: at fasting state, total cholesterol (TG) ≥ 150 mg/dl (1.7mmol/l); and / or HDL-C: male < 35mg/dl (0.9mmol/l), female < 39mg/dl (1.0mmol/l) . The inclusive criteria for patients at high-risk of MetS: A. paticipants are taking antipsychotic drugs that significantly affect metabolisms, such as olanzapine, clozapine or risperidone; B. paticipants have family history of diabetes, hypertension and heart disease; C. the age of paticipants is over 40 years old; D. paticipants have no nonalcoholic fatty liver and gout; E. paticipants who have one or two components of metabolic syndrome but do not meet the diagnostic criteria.

For clinical and biological data collection, we collect blood samples and case information, which contains demographic data, medical history (including current medical history, past history, personal history and family history), medication regimen and results of follow-up evaluation. The biological samples are stored using unique code whose storage information can be linked to research case in the web server.

The Standard Operations Procedures (SOPs) are followed for data collection, storage, tracking, and utilization.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
17 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia;
  • Duration of illness less than 3 years with current symptoms exacerbation;
  • Male and female with aged 17 to 65 years;
  • Signed the study consent for participation

排除标准

  • Having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;
  • Having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
  • Taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;
  • Having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
  • The routine blood tests showing abnormal renal, liver function;
  • Pregnant or lactating women.
  • No administration of any antibiotics in a mouth

研究组 & 干预措施

treatment cohort

in sub-project 1, participants are randomized into olanzapine, risperidone, aripiprazole, amisulpride, ziprasidone, and haloperidol groups, we give them evaluation, and adjust dose of medication and deal with side effect if necessary.

干预措施: antipsychotic medications (Drug)

adjunctive group

Patients who do not have an ideal response to antipsychotics treatment (reduction rate of Positive and Negative Symptom Scale (PANSS) score less than 25%) in sub-project 2 are recruited in this trial. They are randomly assigned to antipsychotic plus placebo, antipsychotic plus sulforaphane(3 tables per day, consisting of 30 mg of SFN-glucosinolate per day), and antipsychotic plus minocycline(200mg per day) groups, and the antipsychotic drugs used at this stage are still consistent with the first trial of sub-project 2. At baseline, 4 weeks and 8 weeks after treatment, all participants receive evaluations.

干预措施: adjunctive group (Drug)

metformin and lifestyle intervention for MetS

Participants who develop MetS at the last visit in sub-project 1 and sub-project 2 are recruited in this trial. Patients are randomized into low-dose metformin (1000 mg/d), high-dose metformin (1500 mg/d), low dose metformin plus lifestyle intervention group (1000 mg/d), high dose metformin plus lifestyle intervention (1500 mg/d), lifestyle intervention, and placebo groups. The timepoints of the visits are at baseline, the 4th week, the 8th week, and the 12th week.

干预措施: metformin and lifestyle intervention (Drug)

metformin and lifestyle prevention for high risk of MetS

Participants who are at a high risk of MetS are recruited in this trial. Participants are randomized into low dose metformin (750 mg/d), high dose metformin (1000 mg/d), lifestyle intervention, and placebo groups. The timepoints of the visits are at baseline, the 4th week, the 8th week, and the 12th week.

干预措施: metformin and lifestyle intervention (Drug)

validation cohort

in sub-project 2, there are1,800 first-episode schizophrenia patients recruited from 19 hospitals, and six groups as with sub-project 1. The assessments (timepoint and content) are conducted as in sub-project 1.

干预措施: antipsychotic medications (Drug)

结局指标

主要结局

Positive And Negative Syndrome Scale (PANSS)

时间窗: 8 weeks

The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point.

Clinical Global Impressions(CGI)

时间窗: 8 weeks

The change of Clinical Global Impressions(CGI):severity of illness(SI), global improvement(GI) and efficacy index(EI) before and after treatment at different follow up point.

Global Assessment Function(GAF)

时间窗: 8 weeks

The change of Global Assessment Function(GAF) before and after treatment at different follow up point.

MATRICS Consensus Cognitive Battery (MCCB) composite score

时间窗: 8 weeks

The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure before and after treatment at different follow up point.

次要结局

未报告次要终点

研究者

发起方
Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Renrong Wu,PhD

M.D,Ph.D,Professor

Central South University

研究点 (1)

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