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

 Professional technicians are employed for the establishment and subsequent maintenance of
 Internet platform, including web server and mobile terminal applications (APP). Ancillary
 researchers are involved for collection and timely upload of case information online.
 Principal investigators are responsible for auditing the data and quality control.
Inclusion Criteria:

 1. Meet the Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for
 schizophrenia;

 2. Duration of illness less than 3 years with current symptoms exacerbation;

 3. Male and female with aged 17 to 65 years;

 4. Signed the study consent for participation

 Exclusion Criteria:

 1. Having history of substance dependence or abuse or whose symptoms are caused by the
 other diagnosable mental disorders;

 2. Having history of traumatic brain injury, seizures or other known neurological or
 organic diseases of the central nervous system;

 3. Taking antidepressants, stimulants, mood stabilizer or accepts electricity shock
 treatment;

 4. Having current suicidal or homicidal thoughts or any safety concern by research staff
 that cannot be manage in an inpatient setting;

 5. The routine blood tests showing abnormal renal, liver function;

 6. Pregnant or lactating women.

 7. No administration of any antibiotics in a mouth