Study on the Gut Microbial Mechanism of Negative Symptoms of Schizophrenia

• Status: Not yet recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Mental Health Center
• Treatments: Amisulpride

Criteria

Inclusion Criteria:

• 18-45 years old, Han nationality, no gender limit;

• Meet the diagnostic criteria of "Schizophrenia" in the American Diagnostic Standards for Mental Disorders (DSM-V);

• The first attack, no antipsychotic drugs have been used in the past six months;

• The PANSS negative symptom subscale has at least 3 items with 4 points and above or at least two items with 5 points and above, and the positive symptoms score is less than 19 points;

• The negative symptom score is at least 6 points or more higher than the positive symptom score;

• The cultural, social and educational background is sufficient to understand informed consent and research content.

Exclusion Criteria:

• 1.Combined with DSM-V diagnosis other than schizophrenia;

• .G6≥4 points in PANSS, or CDSS≥6 points;

• .SAS Side Reaction Scale> 3 points;

• Organic diseases of the central nervous system;

• In the past two months, there were people who were dependent or abused on alcohol or other substances, which caused significant impairment of social and cognitive function;

• In the past year, there have been major life events such as widowhood;

• Serious suicide attempts;

• .The current patient's severe and unstable physical disease;

• .Pregnant and lactating women;

• Have a history of antibiotic use of more than 3 days within 3 months;

• Use probiotics (lactic acid products, etc.) for more than 3 days within 3 months;

• Type 1 diabetes and severe diabetes complications;

• .Digestive system diseases such as gastrointestinal inflammation, acute or chronic hepatitis;

• .Severe organ diseases, such as cancer, coronary heart disease, myocardial infarction, cerebral hemorrhage;

• .Have infectious diseases, such as tuberculosis, AIDS;

• Drug treatment of cholecystitis, peptic ulcer, urinary tract infection, acute nephritis, cystitis or hyperthyroidism.