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
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
- Negative Symptom
- Schizophrenia
- Amisulpride
- Gut Microbiomes
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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