Study on the Gut Microbial Mechanism of Negative Symptoms of Schizophrenia

NCT04533724 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-09-01

No results posted yet for this study

Summary

Negative symptoms are one of the five-dimensional symptoms of patients with schizophrenia, and medications are not effective in treating negative symptoms. The mechanism of negative symptoms of schizophrenia is unknown, which may be related to insufficient dopamine function of the prefrontal cortex. Amisulpride is a D2/D3 receptor antagonist, which can improve negative symptoms. Intestinal microbes are related to central nervous system mental diseases. Animal studies have found that changes in the intestinal microflora are related to schizophrenia. Clinical studies have found that the gut microbes of patients with schizophrenia are different from those of normal healthy people. Therefore, we are trying to discover the changes of gut microbes in patients with effective amisulpride treatment, and to improve the negative symptoms of schizophrenia patients through the intestinal immune system. The mechanism of brain relationship provides direction, and also provides a new way for the drug treatment of negative symptoms.

Conditions

Interventions

DRUG

Amisulpride

The amisulpride treatment group was given amisulpride tablets. The dose: the initial dose was 50 mg/d. The doctor titrated the dose to the therapeutic amount within 1 to 2 weeks according to the patient's condition. The maximum dose was 300 mg/d, taken with a single meal. Observe for 8 weeks.

Sponsors & Collaborators

  • Shanghai Mental Health Center

    lead OTHER

Principal Investigators

  • Qinyu Lv · Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  • Qi Zhang · Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  • Zhenghui Yi · Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  • Congze Wang · Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  • Huanling Zhang · Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

  • Xinxin Huang · Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-09-01
Completion
2022-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04533724 on ClinicalTrials.gov