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

Summary

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.

Conditions

• Schizophrenia
• Metabolic Syndrome

Interventions

DRUG

antipsychotic medications

olanzapine, risperidone, aripiprazole, amisulpride, ziprasidone, and haloperidol groups

DRUG

adjunctive group

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.

DRUG

metformin and lifestyle intervention

different dose metformin combines lifestyle intervention

Sponsors & Collaborators

• Xiangya Hospital of Central South University

  collaborator OTHER

• Shanghai Mental Health Center

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Air Force Military Medical University, China

  collaborator OTHER

• Jiangsu Province Nanjing Brain Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Shanxi Medical University

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Guangzhou Mental Hospital

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Capital Medical University

  collaborator OTHER

• China Medical University, China

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Hebei Medical University

  collaborator OTHER

• Shenzhen Mental Health Center

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Wuhan Mental Health Centre

  collaborator OTHER

• Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Central South University

  lead OTHER

Eligibility

Min Age

17 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-23

Primary Completion

2021-06-30

Completion

2021-06-30

Countries

• China

Study Locations